BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BED

    MDR report key: 4080813 · Received August 28, 2014

    Report

    Report Number
    1824206-2014-02181
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    KNC
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH FOUND THE HEAD END LIFT ARM STRAPS WERE MISSING. HE PROVIDED THE ACCOUNT THE PARTS NEEDED AND IS AWAITING THEIR APPROVAL. PER THE HILL-ROM SERVICE MANUAL THE AFFINITY THREE BIRTHING BED AND AFFINITY FOUR BIRTHING BEDS REQUIRE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM SEMIANNUAL PREVENTIVE MAINTENANCE. EXAMINE THE PIVOT POINT FASTENERS SEMI-ANNUALLY. FAILURE TO DO SO COULD CAUSE INJURY OR DAMAGE. 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. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADD'L RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXPECTANTLY TIPPED INTO A TREND LIKE POSITION. THE BED WAS LOCATED IN THE LABOR WARD AT THE ACCOUNT. 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
    523651 AFFINITY 4 BED BIRTHING BED KNC HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1