BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHTO IRRIGATION PUMP

    MDR report key: 2964583 · Received February 15, 2013

    Report

    Report Number
    0002936485-2013-00029
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCX
    PMA / PMN Number
    K042454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE PRODUCT WAS RECEIVED WITH THE WARRANTY SEAL BROKEN, SCRATCHES AND DENTS ON HOUSING. THE UNIT WAS OPENED AND NOTICED THE BURNT POWER SUPPLY, MAINBOARD, BURNT HOLE ON THE BATTERY PACK AND BURNT HOLE ON THE CHASSIS. IT WAS ALSO NOTICED THAT THE BATTERY PACK WAS DISCONNECTED AND MAINBOARD WAS NOT PROPERLY MOUNTED, THE NYLON SCREW HEADS WERE MISSING. ONE OF THE LOCKNUT FOR THE POWER RECEPTACLE WAS LOOSE, THIS COULD HAVE TOUCHED OTHER COMPONENTS THAT COULD HAVE TRIGGERED THE SPARK THAT RESULTED FOR THE BURNT COMPONENTS. POSSIBLE ROOT CAUSES COULD BE THE UNIT WAS OPENED AND REPAIRED BY THIRD PARTY DUE TO BROKEN SEAL AND THE BROKEN NYLON SCREWS AND/OR USER MISUSE.IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS EMITTING SMOKE AFTER IT WAS PLUGGED IN TO CHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS EMITTING SMOKE AFTER IT WAS PLUGGED IN TO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66467 AHTO IRRIGATION PUMP APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1