BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 3896369 · Received May 20, 2014

    Report

    Report Number
    1824206-2014-01605
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RENTAL BED COULD NOT BE REPAIRED AT THE ACCOUNT AND WAS SWAPPED FOR A KNOWN WORKING BED. THE TECHNICIAN FOUND THE LEFT SIDE RAIL WAS ABLE TO BE RAISED UP, ALMOST TO THE FULL UP POSITION, BUT IT WOULD NOT LATCH, DUE TO THE LATCH COVER BEING BENT. THE MOST LIKELY CAUSE OF THE BENT LATCH COVER IS FORCE. THE TECHNICIAN REPAIRED THE LEFT SIDE RAIL LATCH COVER BY BENDING IT BACK INTO PROPER POSITION TO RESOLVE THIS ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE LEFT SIDE RAIL WILL NOT STAY LATCHED. THE BED WAS LOCATE DIN ROOM 313-1. THERE WAS NO PT/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
    300713 TOTALCARE BARIATRIC PLUS BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1