BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1910906 · Received November 23, 2010

    Report

    Report Number
    1824206-2010-11257
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT THINKS THE ISSUE IS INTERMITTENT. IT WAS WORKING WHEN HE FIRST TESTED THE BED AND THE BED WILL PLACE A NURSE CALL BUT NOT A PRIORITY CALL. THE ACCOUNT REPLACED THE SIDECOM BOARD TO RESOLVE THE PROBLEM

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THEY SET THE PT POSITIONING MONITOR (PPM) AND THE PT GOT OUT OF BED AND FELL AND THE PPM ALARM DID NOT ALARM. THE PT WAS NOT INJURED.

    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