BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAGE IV

    MDR report key: 1481614 · Received September 18, 2009

    Report

    Report Number
    MW5012807
    Event Type
    Malfunction
    Date Received
    September 18, 2009
    Date of Event
    September 7, 2009
    Report Date
    September 18, 2009
    Manufacturer
    SENTECH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAFFLES DID NOT INFLATE PROPERLY WHEN BED IN SITTING POSITION. PT HAD C/O OF DISCOMFORT BUT NO HARM NOTED. ITEM WAS IN USE FOR EIGHT DAYS IN 2009. ON THE LAST DAY, DEFECTIVE UNIT REPLACED. TWO DAYS LATER, DEFECTIVE UNIT PICKED UP BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAGE IV BARIATRIC MATTRESS FNL SENTECH SYS300HG-48

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR