BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2063114 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01632
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REMOVED, DISASSEMBLED, CLEANED, REASSEMBLED, AND REINSTALLED THE HI/LOW DRIVE TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE BED HAD HI/LOW DRIFT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1