BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3240852 · Received July 16, 2013

    Report

    Report Number
    1824206-2013-03520
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPORTS THAT THERE IS NO ISSUE WITH BED. THE ACCOUNT TESTED THE BED WITH WEIGHT IN BED AND THE PT POSITION MODULE SET AND ALARMED IN ALL MODES. THE ACCOUNT STATED THE ISSUE WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT TWO OF THE BED EXIT MODES WILL NOT SET. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330327 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1