BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 1893858 · Received November 2, 2010

    Report

    Report Number
    9615739-2010-00251
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE LEFT HEAD SIDERAIL CABLE TO RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE LEFT HEAD SIDERAIL CABLE HAS BECOME FRAYED BY THE CONSTANT RAISING AND LOWERING OF THE SIDERAIL. THE ACCOUNT INDICATED THAT BARE METAL WIRES WERE VISIBLE. A PT WAS NOT IN THE BED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1