BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 3882855 · Received February 21, 2014

    Report

    Report Number
    1824206-2014-00574
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND FOUND THE SIDE RAILS ALL FUNCTION AS DESIGNED, POSSIBLE USER ERROR. THERE WAS NO REPAIR NEEDED, THE BED FUNCTIONS AS DESIGNED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE SIDE RAIL WILL NOT STAY IN THE LATCHED POSITION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110400 TOTALCARE BARIATRIC PLUS BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1