BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2030649 · Received March 22, 2011

    Report

    Report Number
    1824206-2011-01737
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    May 7, 2010
    Report Date
    May 7, 2010
    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

    THE ACCOUNT PUSHED THE BRAKE CASTER BACK INTO PLACE. TECH INSPECTED THE BRAKE CASTER AND RE FITTED THE BRAKE CASTER RETAINING SCREW AND TIGHTENED ALL BRAKE CASTER RETAINING SCREWS 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 FOOT END LEFT BRAKE CASTER HAD FALLEN OFF OF THE BED. NO PT 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