BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-WIDER BARIATRIC BED

    MDR report key: 3458459 · Received October 11, 2013

    Report

    Report Number
    3005179379-2013-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 8, 2013
    Manufacturer
    KREG MEDICAL, INC.
    Product Code
    OSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON A THOROUGH INVESTIGATION BY DISTRIBUTOR, MFR, AND USER FACILITY, IT APPEARS THE POWER CORD WAS IMPROPERLY ROUTED BETWEEN MOVING MEMBERS OF THE UPPER BED FRAME. PRIOR TO THE EVENT, THE PT HAD BEEN MOVED TO MULTIPLE ROOMS WITHIN THE HOSPITAL. CAREGIVERS WERE OPERATING THE BED WHEN THE EVENT OCCURRED. NO INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DISTRIBUTOR, RECEIVED A SERVICE CALL FROM A MEDICAL CENTER FOR A BED THAT REPORTEDLY EMITTED "SMOKE" AFTER HEARING A "POP" SOUND. THE SUBJECT BED WAS RETURNED TO THE COMPANY FOR INSPECTION WHICH REVEALED THE BED'S POWER CORD HAD BEEN CRUSHED AND PUNCTURED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524420 EZ-WIDER BARIATRIC BED OSI KREG MEDICAL, INC. ASM100104 7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK