BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1062754 · Received June 18, 2008

    Report

    Report Number
    1824206-2008-02672
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THE BED WHEN PLUGGED IN, THERE IS A LARGE SPARK EMITTED AT PLUG. FACILITY SAID THEY HAD SOMEONE GOT SHOCKED FROM IT. FACILITY SAID THERE WAS NO INJURIES. FACILITY DID NOT HAVE A SERIAL NUMBER OF THE BED. FACILITY COULD NOT PRODUCE ANY DOCUMENTATION ON AN INCIDENT WHERE SOMEBODY HAD GOTTEN SHOCKED FROM A BED. SHE DID NOT HAVE ANY SPECIFIC BED INVOLVED IN THE ALLEGED EVENT. TSR INSTALLED THE POWER RESISTOR KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P3200

    Patients

    Seq Age Sex Outcome Treatment
    1