BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 3931759 · Received April 15, 2014

    Report

    Report Number
    1824206-2014-01198
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THAT THE BED WAS GOING DOWN ON ITS OWN DUE TO THE LEFT SIDE RAIL COMMUNICATION CABLE MALFUNCTIONING. THIS WAS MOST LIKELY DUE TO NORMAL WEAR AND TEAR. THE LEFT SIDE RAIL COMMUNICATION CABLE WAS REPLACED TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT THE BED WAS MOVING DOWN ON ITS OWN. 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 NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230976 TOTALCARE BARIATRIC PLUS BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1