BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2031725 · Received March 21, 2011

    Report

    Report Number
    1824206-2011-01697
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    November 2, 2009
    Report Date
    November 2, 2009
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BED WAS NOT REPAIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BED HAD A LOSS OF GROUND. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1