BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY IV

    MDR report key: 1843752 · Received September 21, 2010

    Report

    Report Number
    1824206-2010-10040
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 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

    ACCOUNT FOUND THE BRAKE DETENT ASSEMBLY HAD FAILED. ACCOUNT REPLACED THE BRAKE DETENT ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THE BRAKE WAS BROKEN AND NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY IV BIRTHING BED HDD HILL-ROM, INC. P3700B

    Patients

    Seq Age Sex Outcome Treatment
    1