BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2212132 · Received July 8, 2011

    Report

    Report Number
    1824206-2011-03624
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN FOUND THAT THE CPR VALVE WAS NOT FUNCTIONING. REPLACED CPR VALVE TO RESOLVE THIS ISSUE. BED WAS SWAPPED OUT DUE TO THE CUSHION BEING DEFLATED IN THE CTR.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT THE BED WAS ALARMING - NO TURN ASSIST. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1840

    Patients

    Seq Age Sex Outcome Treatment
    1