BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 3868770 · Received May 7, 2014

    Report

    Report Number
    2242352-2014-00517
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. 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 THE T.W. POWER SUPPLY DID NOT OPERATE PROPERLY. THE DEVICE HAS BEEN IN THE OFFICE FOR A FEW WEEKS. THE SALES REP VISITED THE HOSPITAL ON (B)(4) 2014 AND THE POWER SUPPLY TESTED FINE WITH CORD AND HEMOPRO2 HARVESTING TOOL. WARREN COLE IN THE BIOMED DEPT WILL NOT LET POWER SUPPLY PASS BECAUSE THE UNIT DOESN'T MEET THE SPECTS LISTED IN THE PRODUCT SERVICE MANUAL. A SPECIAL RESISTOR IS NEEDED TO PERFORM SPEC TEST ON POWER SUPPLY AND TE HOSPITAL DOESN'T HAVE ACCESS OR RESOURCES TO CERTIFY THE UNIT. NO ADDITIONAL INFO IS AVAILABLE REGARDING HOSPITAL, PT OR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275566 T.W. POWER SUPPLY POWER SUPPLY HQO MAQUET CARDIOVASCULAR, LLC VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1