BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2072898 · Received March 31, 2011

    Report

    Report Number
    1824206-2011-01973
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT SIDERAIL RELEASE LEVER WAS ORDERED FOR THE ACCOUNT. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE SIDERAIL RELEASE LEVER ON THE RIGHT INTERMEDIATE SIDERAIL IS CRACKED IN THE AREA WHERE IT COMES IN CONTACT WITH THE SPRING LATCH, WHICH IS PREVENTING THE SIDERAIL FROM LATCHING. A PT WAS ON THE BED WHEN THE PROBLEM WAS FOUND AND WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK