BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC BED

    MDR report key: 3843722 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00396
    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
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE HEAD END BRAKE CASTERS ARE THE CAUSE. THE TECHNICIAN REPLACED THE HEAD END BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE HEAD END BRAKE CASTERS WILL MOVE WHILE IN BRAKE MODE. THE BED WAS LOCATED IN THE DOWN AREA 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
    93033 TOTALCARE BARIATRIC BED A/C POWERED ADJUSTABLE HOSPITAL BED OSI HILL-ROM, INC. 1830

    Patients

    Seq Age Sex Outcome Treatment
    1