BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3773625 · Received April 4, 2014

    Report

    Report Number
    3008355164-2014-00078
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTAFLOW CONSOLE A WAS NOT CHARGING THE BATTERY WHILE IN USE ON A PATIENT. THE CHARGING LIGHT WAS ON, BUT WHEN PUT ON BATTERY MODE IT WOULD READ 19 VOLTS. THE CUSTOMER SWAPPED OUT THE UNIT FOR A UNIT WITH A NEW BATTERY. NO REPORTED PATIENT EFFECT. (B)(4). REF # MFR 8010762-2014-00177.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205265 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG 70105.1712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention