BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY THREE BIRTHING BED

    MDR report key: 3850831 · Received March 21, 2014

    Report

    Report Number
    1824206-2014-00933
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BRAKE/STEER CASTER NEED TO BE ADJUSTED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOW HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2007-2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN ADJUSTED THE BRAKE/STEER CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN L&D AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169918 AFFINITY THREE BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1