BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 4961913 · Received July 31, 2015

    Report

    Report Number
    2242352-2015-00625
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HEMOPRO GENERATOR DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498857 T.W. POWER SUPPLY T.W. POWER SUPPLY HQO MAQUET CARDIOVASCULAR LLC C-VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1