BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1960134 · Received December 17, 2010

    Report

    Report Number
    1824206-2010-11730
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE BRAKE-OFF ALARM WOULDN'T SOUND WHEN THE BRAKE WAS OFF AND THE BED WAS STILL PLUNGED IN. HE REPLACED THE POWER SUPPLY BOARD TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES 'THE BRAKE NOT SET' ALARM WILL NOT ACTIVATE WHEN THE BRAKES ARE NOT SET. THE BED WAS PLUGGED INTO AN OUTLET WITH POWER. THE NURSE ALLEGED A PATIENT WAS GETTING INTO THE BED AND IT ROLLED AWAY FROM THE PATIENT. THE NURSE WAS ABLE TO CATCH THE PATIENT TO PREVENT THE PATIENT FROM FALLING. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK