BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 3932191 · Received April 3, 2014

    Report

    Report Number
    1824206-2014-01088
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT DURING PATIENT INSPECTION THAT THE SIDE RAIL LATCH COVER IS BENT PREVENTING THE SIDE RAIL FROM LATCHING. THE MOST LIKELY CAUSE OF THE BENT LATCH COVER IS FORCE. THE TECHNICIAN REPLACED THE HEAD LEFT SIDE RAIL LATCH COVER TO RESOLVE THE ISSUE.. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE HEAD LEFT SIDE RAIL WILL NOT LATCH IN THE UP POSITION. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. 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
    200614 TOTALCARE BARIATRIC PLUS BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1