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HAMO LS 2000 WASHER|STERIS AG Reports
Medical Device Brand: HAMO LS-2000 WASHER
Medical Device Generic: WASHER - DISINFECTOR
Medical Device Manufacturer:STERIS AG


HAMO LS-2000 WASHER Report # 1381019
A STERIS TECHNICIAN EXAMINED THE WASHER AND FOUND THAT THE BRACKET/ARM WHICH SUPPORTED THE LEFT SIDE OF THE DOOR WAS BROKEN. ON THE RIGHT SIDE, THE STOPPER CONNECTED TO THE SPRING WAS BROKEN IN HALF. THE INVESTIGATION SHOWED THAT THE STOPPER MOST LIKELY BROKE FIRST, RESULTING IN STRESS ON THE BRACKET/ARM WHEN THE WEIGHT OF THE DOOR SHIFTED. ALL THE STOPPERS ON THIS UNIT WERE REPLACED, AS WAS THE BRACKET/ARM, AND THE UNIT IS NOW FUNCTIONING PROPERLY. THE UNIT WAS MANUFACTURED IN 2000, AND THIS IS THE FIRST TIME SUCH AN EVENT HAS OCCURRED WITH THIS DOOR DESIGN. THE CONDITION OF THESE STOPPERS SHOULD BE VISUALLY EXAMINED FOR CRACKING OR DISCOLORATION DURING PREVENTIVE MAINTENANCE AND REPLACED IF WEAR IS EVIDENT. THE MAINTENANCE INSTRUCTIONS FOR THIS DEVICE ARE BEING REVISED TO RECOMMEND REPLACEMENT OF THE STOPPERS AT 2 YEAR INTERVALS REGARDLESS OF APPEARANCE.

HAMO LS-2000 WASHER Report # 1381019
AT THE END OF THE WASHER CYCLE, THE OPERATOR OPENED THE DOOR FROM THE CLEAN SIDE AND BEGAN TO PULL THE CARRIAGE HOLDING THE BASKET OF CLEAN INSTRUMENTS FROM THE UNIT. AS SHE DID THIS, THE WASHER DOOR FELL, KNOCKING THE CARRIAGE ONTO THE OPERATOR¿S ARM. THE OPERATOR WENT TO THE EMERGENCY ROOM FOR AN X-RAY OF HER ARM, WHERE IT WAS DETERMINED THAT HER ARM WAS ONLY BRUISED.


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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.
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