BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BED

    MDR report key: 2061956 · Received March 18, 2011

    Report

    Report Number
    1824206-2011-01691
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    June 24, 2010
    Report Date
    June 29, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED TWO VALVE SOLENOIDS TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE HEAD OF THE BED WILL NOT LOWER. NO PATIENT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1