BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3240036 · Received July 11, 2013

    Report

    Report Number
    1824206-2013-03470
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    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 MADE ADJUSTMENTS TO THE CARDIO PULMONARY RESUSCITATION CABLES BUT THE ISSUE REMAINED. THE ACCOUNT FOUND THAT THE PIN USED TO ACTIVATE THE CARDIO PULMONARY RESUSCITATION HAD BECOME STUCK IN THE HEAD DRIVE MOTOR. THE ACCOUNT REPLACED THE HEAD DRIVE MOTOR TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED WOULD GO INTO REVERSE TRENDELENBURG WHEN THE CARDIO PULMONARY RESUSCITATION WAS USED, EVEN AFTER LETTING GO OF THE CARDIO PULMONARY RESUSCITATION LEVER THE BED WOULD CONTINUE TO MOVE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321184 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1