BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 2010291 · Received March 1, 2011

    Report

    Report Number
    9615739-2011-00046
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED IS NOT SENDING A NURSE CALL WHEN THE PATIENT POSITIONING MONITOR (PPM) ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1