BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC BED

    MDR report key: 3843723 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00397
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. A FOLLOW UP REPORT WILL BE SENT ONCE THIS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKES WERE NOT HOLDING WHEN THE BRAKES WERE SET. THE BED IS LOCATED IN STORAGE AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93836 TOTALCARE BARIATRIC BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1