BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 1945235 · Received December 10, 2010

    Report

    Report Number
    9615739-2010-00297
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 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 ACCOUNTS MAINTENANCE REPLACED THE RIGHT SIDERAIL CABLE AND OVERLAY TO RESOLVE THE PROBLEM. THEY STATED THE EXACT CAUSE OF THE PROBLEM IS NOT KNOWN.

    Description of Event or Problem · 1

    THE ACCOUNTS MAINTENANCE ALLEGED THE BED FUNCTIONS WORK INTERMITTENTLY FROM THE RIGHT HEAD SIDERAIL DUE TO THE SIDERAIL CABLE HAVING BROKEN AND EXPOSED WIRING.

    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