BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 2010020 · Received March 2, 2011

    Report

    Report Number
    1824206-2011-01215
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE SCALE BOARD AND THE BUZZER TO REPAIR THE BED. HE CALIBRATED THE SCALE, ZEROED SCALE AND CHECKED SCALE OPERATION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED, THE BED'S PT POSITIONING MONITOR (PPM) WAS NOT MAKING AN AUDIBLE ALARM WHEN THE PT WAS MOVING OR TRYING TO GET OUT OF BED, HOWEVER, THE BED WAS SENDING AN ALARM SIGNAL TO NURSE'S STATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1