BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3032232 · Received March 25, 2013

    Report

    Report Number
    1824206-2013-01617
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND THE ACCOUNT STATED THAT THE BED ALARM WAS SET AND ALLEGEDLY FIFTEEN MINUTES LATER THE PATIENT FELL AFTER LEAVING THE BED. THE BED ALLEGEDLY DID NOT ALARM AND THE ACCOUNT STATED THAT THE BED EXIT ALARM WOULD NOT STAY ON. THE TECHNICIAN ASKED IF HE COULD TEST THE BED AND THE ACCOUNT WOULD NOT LET THE TECHNICIAN TEST THE BED. THE TECHNICIAN WAS ONLY ABLE TO GET A STATEMENT FROM THE ACCOUNT. THE ACCOUNT DID STATE THERE WAS NO INJURY DUE TO THE FALL.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE PATIENT POSITION MODULE WILL SET AND SHUT OFF BY ITSELF. THIS RESULTED IN A PATIENT FALL AND NO INJURY OCCURRED DUE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121663 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other