BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS W/AIR BED

    MDR report key: 3952183 · Received May 13, 2014

    Report

    Report Number
    1824206-2014-01474
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE POWER CORD HAD FLASH MARKS AND BURN MARKS ON THE PLUG AND ALSO THE POWER CORD PRONGS WERE BENT OVER, MOST LIKELY CAUSED BY DAMAGE OR USER ERROR SUCH AS THE BED NOT BEING UNPLUGGED BEFORE TRANSPORT. THE BED WAS SWAPPED FOR A KNOWN WORKING BED. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE ISSUE AT THE HILL-ROM WAREHOUSE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT SPARKS ARE COMING OUT OF THE PLUG ON THE POWER CORD. THE BED WAS LOCATED IN THE STORE ROOM ON THE FIRST FLOOR AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286861 TOTALCARE BARIATRIC PLUS W/AIR BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1