BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 2142577 · Received June 21, 2011

    Report

    Report Number
    1824206-2011-03346
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD TECHNICIAN FOUND THE AIR BLOWER BOX COMING INTO CONTACT WITH THE CROSS ARM OF THE LIFT ARM. HE NOTICED PAINT WAS SCRAPED FROM THE BAR AND THE BLOWER BOX. THE ACCOUNT CHECKED ALL VERSACARE BEDS AND FOUND 11 MORE BEDS WITH SAME ISSUES, ALL DEEMED UNSAFE BY HOSPITAL'S ADMIRAL AND TAKEN OUT OF SERVICE. WORKING WITH THE ACCOUNTS BIOMED, THE TECHNICIAN FOUND REVERSING THE DIRECTION AND INSTALLING BRACKETS UPSIDE DOWN, IMPROVED GAP BETWEEN THE LIFT ARM BY ALMOST 2 INCHES. THE ACCOUNT RETURNED THE BEDS TO SERVICE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE BED DROPPED APPROX 1 INCH AT THE HEAD HI/LO SECTION WITH A PATIENT ON THE BED.

    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