BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 755925 · Received October 27, 2005

    Report

    Report Number
    2084725-2005-00460
    Event Type
    Malfunction
    Date Received
    October 27, 2005
    Report Date
    October 5, 2005
    Manufacturer
    MINNTECH CORP
    Product Code
    FEB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH FACILITY REVEALED THAT UNUSED TUBING THAT SHOULD HAVE BEEN REMOVED PRIOR TO PROCESSING ENDOSCOPES HAD "WHIPPED" AROUND AND SPRAYED WATER OVER THE MACHINE SWITCH AND OTHER PARTS OF THE UNIT, AS WELL AS THE WALL. THE GSI OUTLET BECAME TRIPPED. WHEN THE BIOMED ENGINEER TRIED TO TURN OFF THE SWTICH, HE EXPERIENCED AN ELECTRICAL SHOCK DESCRIBED AS A "BUZZ." NO MEDICAL ATTENTION WAS SOUGHT AND NO PHYSICAL MARKS WERE ON HIS HANDS WHEN THE AER 387 WAS CHECKED BY ASP FIELD SERVICE ENGINEER, THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM WAS VERIFIED AS PROPERLY GROUNDED. THE SYSTEM MEETS PRODUCT SPECIFICATIONS. THE AER SERVICE GUIDE'S SECTION ON SAFETY INCLUDES A STATEMENT. "LIVE ELECTRICITY IS PRESENT WHEN SERVICE BOX IS IN USE. TURN OFF ALL SWITCHES AND REMOVE SERVICE BOX WHEN PROCEDURES CALL FOR THIS ACTION." THE SECTION ON TROUBLESHOOTING ALSO HAS A WARNING STATEMENT REGARDING POSSIBLE ELECTRICAL SHOCK HAZARDS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION DUE TO CUSTOMER NOT FOLLOWING THE AER SERVICE GUIDE.

    Description of Event or Problem · 1

    BIOMEDICAL ENGINEER EXPERIENCED AN ELECTRICAL SHOCK WHEN HE TRIED TO TURN THE UNIT OFF. CONSULATATION WITH THE FIELD SERVICE ENGINEER REVEALED THE FACILITY HAD NOT REMOVED UNUSED TUBING IN THE AER THAT WAS NOT CONNECTED TO AN ENDOSCOPE FOR PROCESSING. WHEN THE AER WAS PROCESSING THE SCOPE CORRECTLY CONNECTED TO THE TUBES, THE TUBES NOT IN USE WERE WHIPPED AROUND AND SPRAYED WATER OUT OF THE UNIT. AS A RESULT, THE MACHINE SWITCH AND OTHER PARTS NOT WET. IN THIS CASE THE WELL ALSO GOT WET AND THE GFI OUTLET WAS TRIPPED. THE WORKER WAS SHOCKED AS HE CONTACTED THE WET POWER SWWITCH ON THE DEVICE. THE SHOCK WAS DESCRIBED AS A "BUZZ." THE WORKER DID NOT SEEK MEDICAL ATTENTION AND DID NOT HAVE ANY PHYSICAL MARKS ON HIS HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC ENDOSCOPE REPROCESSOR AUTOMATIC ENDOSCOPE REPROCESSOR FEB MINNTECH CORP 20301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *