BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 2822097 · Received October 10, 2012

    Report

    Report Number
    9615739-2012-00353
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT TEST THE BED WITH A SIDECOM TESTER AND FOUND A CONTINUOUS NURSE CALL CAUSED BY THE AUXILIARY DUMMY PLUG BEING DISLODGED. THE ACCOUNT RESEATED THE AUXILLIARY DUMMY PLUG TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE BED SENDS AN INTERMITTENT NURSE CALL. NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1