BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 1904158 · Received November 15, 2010

    Report

    Report Number
    9615739-2010-00261
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE PT POSITIONING MONITOR (PPM) WAS ARMED AND THE PT GOT OUT OF BED AND THE ALARM DID NOT GO OFF AND THE PPM WAS STILL SET. 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