BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BIRTHING BED

    MDR report key: 3925088 · Received June 17, 2014

    Report

    Report Number
    1824206-2014-01790
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT ASKED THE ACCOUNT TO ISOLATE THE SIDE RAILS OF THE BED TO TROUBLESHOOT THE CAUSE OF THE HEAD SECTION SELF-RUN. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THREE ATTEMPTS HAVE BEEN MADE REGARDING A RESOLUTION WITH NO FEEDBACK FROM THE ACCOUNT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE HEAD SECTION WILL RAISE WHEN THE BED IS PLUGGED IN AND NO SWITCH IS DEPRESSED. THE BED WAS LOCATED AT THE FACILITY. THERE WAS NO PT/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
    355945 AFFINITY 4 BIRTHING BED BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1