BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1982362 · Received January 13, 2011

    Report

    Report Number
    1824206-2011-00160
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN ASKED THE ACCOUNT TO CLEAN THE HI/LO DRIVE SCREW. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THIS BED. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE HI/LOW WAS DRIFTING. NO PT IMPACT.

    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