BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARIL0A BARIATRIC BED

    MDR report key: 2560541 · Received April 26, 2012

    Report

    Report Number
    2182305-2012-00014
    Event Type
    Other
    Date Received
    April 26, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 23, 2012
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR, BY DEALER, (B)(4), PER DEALER, ALL WIRES ON THE BED WERE EXPOSED AND CAUGHT ON FIRE WITH PT ON THE BED. THE PT WAS UNINJURED. FURTHER INVESTIGATION CONFIRMED NO PT INJURY. PER FACILITY, "THE WIRE INSIDE THE WALL BROKE AND CAME LOOSE INSIDE THE PLUG. WHEN THE BED WAS PLUGGED IN, IT SPARKED AND CAUSES A FIRE. THE INSULATION ON THE SPIRAL CORD WAS LOOSE AND HAD EXPOSED WIRES WHICH MADE IT DOUBLY DANGEROUS". PER FACILITY, THE ISSUE WAS WITH THE PLUG, NOT THE BED. UPON RECEIPT OF THE BED, PRELIMINARY INVESTIGATION INDICATES USER ABUSE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARIL0A BARIATRIC BED HOSPITAL BED FNL JOERNS HEALTHCARE BARIL0A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR