BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 2020088 · Received March 10, 2011

    Report

    Report Number
    1824206-2011-01439
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INSPECTED THE BEDS AND COULD NOT DUPLICATE THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE PATIENT POSITIONING MONITOR (PPM) WOULD ALARM WHEN THE PATIENT EXITED THE BED ON THE RIGHT SIDE, BUT IT DID NOT ALARM WHEN THE PATIENT EXITED FROM THE LEFT SIDE OF THE BED. NO INJURIES.

    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 UNK