Medical Device Index: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z


PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Reports 1998-2010
Medical Device Brand Name: TRAM
Medical Device Generic Name: PHYSIOLOGIC PATIENT MONITOR
Medical Device Manufacturer Name:GE HEALTHCARE


PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 648237
CUSTOMER REPORTED THE TRAMSCOPE WAS READING THE PATIENT'S SP02 INCORRECTLY, FOLLOWING A CHECK OF ARTERIAL BLOOD GASES. DURING THE EVENT, THE PATIENT REPORTEDLY BECAME UNRESPONSIVE, REQUIRED RESPIRATORY SUPPORT, AND WAS THEN INTUBATED. AFTER A STAY IN THE ICU, THE PATIENT WAS REPORTEDLY TRANSFERRED TO A BRAIN INJURY UNIT FOR REHABILITATION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORT EVENT IS ONGOING.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 648237
THE CUSTOMER CANNOT PROVIDE A SERIAL NUMBER, THEREFORE, THE MANUFACTURING DATE CANNOT BE DETERMINED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 771013
CUSTOMER REPORTED WHEN DEVICE WAS POWERED ON, SPARKS FROM THE SOCKET WERE NOTED AND LOUD NOISE WAS HEARD FROM THE SAME AREA. GE HEATHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 768256
CUSTOMER REPORTED PT WENT INTO CARDIAC ARREST AND UNIT DID NOT ALARM. PT SUBSEQUENTLY DIED. CUSTOMER STATED THE PATIENT DEATH IS NOT RELATED TO A MALFUNCTION OF THE EQUIPMENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 757185

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 757185
CUSTOMER REPORTED THERE WAS NO ALARM WHEN A SUPRAVENTRICULAR TACHYCARDIA SWITCHED TO VENTRICULAR TACHYCARDIA. PATIENT SUBSEQUENTLY DIED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 726017
CUSTOMER REPORTED DIASTOLEC READINGS ARE 20-30 MMHG HIGHER THAN EXPECTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRANCE IS STILL ONGOING.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 708267
THEY HAD MEDICATED A PATIENT FOR HIGH BLOOD PRESSURE BASED ON THE PROCARE READING. IT WAS LATER DETERMINED THAT THE PATIENT DID NOT HAVE BLOOD PRESSURE. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 708161
NIBP IS READING HIGH IN THE DIASTOLIC WINDOW. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURENCE IS STILL ONGOING.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 661213
CUSTOMER REPORTED A PATIENT WAS FOUND BY A NURSE WITH NO PULSE OR RESPIRATORY EFFORT. ACCORDING TO THE NURSE, THE DASH MONITOR DID NOT ALARM, VISUALLY OR AUDIBLY. THE PATIENT REPORTEDLY DIED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 917934
CUSTOMER REPORTED ARRHYTHMIA ALARM LEVELS HAD REVERTED TO MFG DEFAULTS (ADVISORY INSTEAD OF CRISIS). THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 917933
CUSTOMER REPORTED ARRHYTHMIA ALARM LEVELS HAD REVERTED TO MFG DEFAULTS (ADVISORY INSTEAD OF CRISIS). THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 917932
CUSTOMER REPORTED ARRHYTHMIA ALARM LEVELS HAD REVERTED TO MFG DEFAULTS (ADVISORY INSTEAD OF CRISIS). THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 917930
CUSTOMER REPORTED ARRHYTHMIA ALARM LEVELS HAD REVERTED TO MFG DEFAULTS (ADVISORY INSTEAD OF CRISIS). THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 917929
CUSTOMER REPORTED ARRHYTHMIA ALARM LEVELS HAD REVERTED TO MFG DEFAULTS (ADVISORY INSTEAD OF CRISIS). THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 915820
CUSTOMER REPORTED THAT MONITOR READING SPO2 READING OF 97-98%, NURSE WENT TO ASSESS THE INFANT AND NOTICED INFANT GRAYISH/BLUE IN COLOR, ATTACHED NELLCOR STAND ALONE UNIT AND SPO2 WAS 70%. THIS HAS BEEN NOTED ON 3 ROOMS, BEDS 6, 19, 20 ON SEPARATE DAYS OVER THE PAST MONTH. BIOMED HAS TESTED USING NELLCOR SIMULATOR AND CANNOT REPRODUCE, SOLAR'S MOUNTED TO WALL, TRAMS DO NOT MOVE FROM ONE ROOM TO ANOTHER. UNIT HAS 25 SOLAR MONITORS. STAFF HAS ONLY NOTICED THIS WHEN SIGNIFICANT DESAT HAS OCCURRED. PROBES LOCATED ON FEET. NO BILI LIGHT IN USE. NO INJURY TO PT.

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 915820
PART RETURNED TO GE FOR INVESTIGATION AND IT WAS DETERMINED THAT THE CARE UNIT IS UTILIZING WRONG SPO2 INTERCONNECT CABLE P/N 407252-002 WITH TRAM 451N MODULES. SPO2 INTERCONNECT CABLE P/N 407252-002 IS INCOMPATIBLE WITH THE TRAM 451N MODULES AND MAY RESULT IN INCORRECT SPO2 VALUES. THE P/N 407252-002 CABLE CONNECTOR IS KEYED AND THIS KEY DOES NOT MATCH THE KEYING ON THE 451N OXISMART TRAM MODULE. IN ORDER TO CONNECT THE CABLE TO THE MONITOR THE KEY WOULD NEED TO BE DEFEATED (I.E. BROKEN). GE HEALTHCARE CONFIRMED THAT BOTH NEONATAL ICU AND HOSPITAL HAVE BEEN PURGED OF INCOMPATIBLE SPO2 INTERCONNECT CABLE P/N 407252-002. CABLES HAVE BEEN REPLACED WITH COMPATIBLE 200644-001 NELLCOR SPO2 INTERCONNECT CABLE. SPO2 TRAM MODULE AND CABLE COMPATIBILITY IS ADEQUATELY DESCRIBED IN LABELING VIA THE SOLAR 8000M PT MONITOR OPERATOR'S MANUAL, VERSION 4, 2000701-107 CHAPTER 14, "SPO2": SECTION "INTRODUCTION", SUBSECTION, "MODULE AND PROBE COMPATIBILITY", "WARNING", "TRAM 451N AND TRAM 851N MODULES REQUIRE NELLCOR OXISMART XL CABLES AND PROBES. OLDER (NON-OXISMART XL) CABLES MUST NOT BE PLUGGED INTO THE SPO2 CONNECTOR ON THESE MODULES. USE OF NON-OXISMART XL CABLES MAY RESULT IN ERRONEOUS READINGS." AND "NOTE"; THE SPO2 CABLE SHOULD PLUG INTO THE MODULE'S SPO2 CONNECTOR EASILY AND SECURELY. DO NOT USE EXCESSIVE FORCE TO CONNECT THE CABLE. IF THE SPO2 CABLE DOES NOT EASILY FIT INTO THE SPO2 CONNECTOR ON THE MODULE, IT IS LIKELY THAT YOU DO NOT HAVE THE APPROPRIATE CABLE FOR THAT MODULE."

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 915816
REPORT STATED "MARQUETTE MONITOR PULSE OXIMETER READING WAS BETWEEN 99 -100, WITH HEART RATE BETWEEN 190 - 192, BUT BABY CRYING, IRRITABLE, AND DUSKY IN COLOR. NURSE PLACED BABY ON ANOTHER BRAND OF PULSE OXIMETER MONITOR, SATURATION READING WAS BETWEEN 71 - 73. NURSE FELT THIS TO BE MORE REFLECTIVE OF BABY'S CLINICAL REPRESENTATION."

PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Report # 915816
PART RETURNED TO GE FOR INVESTIGATION AND IT WAS DETERMINED THAT THE CARE UNIT IS UTILIZING WRONG SPO2 INTERCONNECT CABLE P/N 407252-002 WITH TRAM 451N MODULES. SPO2 INTERCONNECT CABLE P/N 407252-002 IS INCOMPATIBLE WITH THE TRAM 451N MODULES AND MAY RESULT IN INCORRECT SPO2 VALUES. THE P/N 407252-002 CABLE CONNECTOR IS KEYED AND THIS KEY DOES NOT MATCH THE KEYING ON THE 451N OXISMART TRAM MODULE. IN ORDER TO CONNECT THE CABLE TO THE MONITOR, THE KEY WOULD NEED TO BE DEFEATED (I.E. BROKEN). GE HEALTHCARE CONFIRMED THAT BOTH NEONATAL ICU AND HOSP HAVE BEEN PURGED OF INCOMPATIBLE SPO2 INTERCONNECT CABLE P/N 407252-002. CABLES HAVE BEEN REPLACED WITH COMPATIBLE 2006644-001 NELLCOR SPO2 INTERCONNECT CABLE. SPO2 TRAM MODULE AND CABLE COMPATIBILITY IS ADEQUATELY DESCRIBED IN LABELING VIA THE SOLAR 8000M PT MONITOR OPERATOR'S MANUAL, VERSION 4, 200701-107 CHAPTER 14, "SPO2": SECTION "INTRODUCTION", SUBSECTION, "MODULE AND PROBE COMPATIBILITY", "WARNING", "TRAM 451N AND TRAM 851N MODULES REQUIRE NELLCOR OXISMART XL CABLES AND PROBES. OLDER (NON-OXISMART XL) CABLES MUST NOT BE PLUGGED INTO THE SPO2 CONNECTOR ON THESE MODULES. USE OF NON-OXISMART XL CABLES MAY RESULT IN ERRONEOUS READINGS." AND "NOTE"; THE SPO2 CABLE SHOULD PLUG INTO THE MODULE'S SPO2 CONNECTOR EASILY AND SECURELY. DO NOT USE EXCESSIVE FORCE TO CONNECT THE CABLE. IF THE SPO2 CABLE DOES NOT EASILY FIT INTO THE SPO2 CONNECTOR ON THE MODULE, IT IS LIKELY THAT YOU DO NOT HAVE THE APPROPRIATE CABLE FOR THAT MODULE.


Loading

Please Share Your PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE Experience, Join the Discussion:
Source: Manufacturer and User Facility Device Experience Database - (MAUDE). MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. The data is updated on a quarterly basis. DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
PatientsVille.com does not provide medical advice, diagnosis or treatment. The information contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments.The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.We hope you found our information about b>PHYSIOLOGIC PATIENT MONITOR GE HEALTHCARE.