BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA

    MDR report key: 1181974 · Received September 26, 2008

    Report

    Report Number
    1824206-2008-03625
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE GROUND LOSS LED WAS FLASHING. NO INJURY REPORTED. UPON INVESTIGATION FOUND THAT THE PLUG RECEPTACLE WAS NOT FULLY SEATED INTO THE WALL OUTLET. RESEATED THE PLUG TO RESOLVE THIS ISSUE. THIS BED IS EQUIPPED WITH A GROUND LOSS INDICATOR TO WARN THE CAREGIVER THAT THERE HAS BEEN A LOSS OF GROUND AND TO MINIMIZE ANY RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK