BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2061910 · Received March 18, 2011

    Report

    Report Number
    1824206-2011-01694
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    August 17, 2009
    Report Date
    August 17, 2009
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT ADJUSTED AND LUBRICATED THE BRAKE PEDAL 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 BRAKE PEDAL WOULD NOT RELEASE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1