BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 2081570 · Received April 13, 2011

    Report

    Report Number
    9615739-2011-00092
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDECOM BOARD WAS REPLACED TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE PATIENT POSITIONING MONITOR (PPM) WAS ARMED AND ALARMED IN THE ROOM BUT NO NURSE CALL WAS PLACED TO THE NURSE STATION. NO INJURIES.

    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 UNK