BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 2233333 · Received July 20, 2011

    Report

    Report Number
    1824206-2011-03845
    Event Type
    Malfunction
    Date Received
    July 20, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE TECHNICIAN ARRIVED AT HOSPITAL THE BED WAS IN USE. THE TECHNICIAN WAS ABLE TO SET PT POSITIONING MONITOR (PPM) AND TESTED THE POSITION ONLY AND THE BED ALARMED. WITH THE PT REMOVED FROM THE BED, THE TECHNICIAN TESTED ALL PPM MODES AND COULD NOT DUPLICATE THE ALLEGED MALFUNCTION. THE TECHNICIAN INSTRUCTED THE HOSPITAL STAFF ON HOW TO SET AND TEST THE PPM SYSTEM.

    Description of Event or Problem · 1

    INFO RECEIVED FROM THE HOSPITAL INDICATES THERE WAS A PT FALL BECAUSE THE ALARM SYSTEM WAS NOT WORKING. THE HOSPITAL HAD THE SIDERAILS DOWN AND THE PT WAS SITTING ON THE LEFT SIDE OF THE BED ON THE FLOOR. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK