BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE SPORT

    MDR report key: 2053569 · Received March 17, 2011

    Report

    Report Number
    1824206-2011-01665
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    December 28, 2009
    Report Date
    December 28, 2009
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE CPR VALVE TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE HEAD OF THE BED LOWERED BY ITSELF. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CARE SPORT A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1