BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1900839 · Received November 9, 2010

    Report

    Report Number
    1824206-2010-10943
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Removal / Correction Number
    Z-0240-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THAT MOD 380 WAS NOT PERFORMED ON THIS BED. THE TECH USED SIDERAIL SPRING KITS FOR ALL FOUR SIDERAILS TO REPAIR THE BED. HILL-ROM INITIATED A FIELD CORRECTIVE ACTION, INTERNALLY KNOWN AS "MOD 380". CONSIGNEES WERE SENT UPGRADE KITS WHICH THEY COULD HAVE THEIR QUALIFIED PERSONNEL INSTALL THEMSELVES FOLLOWING VIDEO INSTRUCTIONS OR THEY COULD CONTACT HILL-ROM FOR ASSISTANCE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE SIDERAIL ARE NOT LOCKING PROPERLY.

    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