BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 3880820 · Received April 9, 2014

    Report

    Report Number
    2242352-2014-00415
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE POWER SUPPLY CORD WAS NOT RETURNED. SCRATCHES AND CRACKS WERE OBSERVED ON POWER SUPPLY. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY CORD AND HEMOPRO TOOL. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST; THE GREEN INDICATORS LIGHTS DID NOT TURN OUTPUT VOLTAGE WAS 0 DC VOLTS. ((B)(4)). WHILE WE CANNOT CONCLUSIVELY DETERMINE; THIS FAILURE IS CONSISTENT WITH HANDLING DAMAGE, AS STATED ON THE IFU "DO NOT DROP THE POWER SUPPLY". THE MFG DAY ON THE POWER SUPPLY WAS MARCH 2010. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT WAS CONFIRMED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE T.W. POWER SUPPLY DEVICE, WOULDN'T TURN ON, THERE WAS NO POWER. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, THE SAME CORDS WERE USED. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214020 T.W. POWER SUPPLY POWER SUPPLY HQO MAQUET CARDIOVASCULAR, LLC VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI