BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 2241342 · Received September 2, 2011

    Report

    Report Number
    1824206-2011-04614
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 8, 2011
    Manufacturer
    HILL-ROM INC
    Product Code
    HDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LEFT CALF SUPPORT FORMER WAS NOT LOCKING DUE TO WEAR AND TEAR ON THE BALL JOINT OF THE CALF SUPPORT ARM. THE BED INVOLVED WAS DUE A SERVICE ON (B)(6) 2011, HOWEVER THE SERVICE AGREEMENT WAS NOT RENEWED BY THE ACCOUNT SO THE BED HAS BEEN IN CONSTANT USE FOR (B)(6) SINCE ITS LAST SERVICE. THE AFFINITY FOUR BIRTHING BEDS REQUIRE AN EFFECTIVE MAINTENANCE PROGRAM. THE AFFINITY THREE BIRTHING BED AND AFFINITY FOUR BIRTHING BEDS SERVICE MANUAL ((B)(4)) STATES: "WE RECOMMEND THAT YOU PERFORM SEMI-ANNUAL PREVENTIVE MAINTENANCE (PM)". THE PREVENTIVE MAINTENANCE SCHEDULE OF THE SERVICE MANUAL INCLUDES CALF SUPPORTS AND STATES: "CHECK THE LATCH/RELEASE MECHANISM FOR PROPER OPERATION. VERIFY FREE ROTATION TO ENSURE THERE IS NO BINDING. WHEN THE RELEASE HANDLE IS ROTATED TO THE RIGHT (CLOCKWISE), THE BALL JOINT SHOULD TIGHTEN; WHEN ROTATED TO THE LEFT (COUNTERCLOCKWISE), THE BALL JOINT SHOULD LOOSEN. REPAIR OR REPLACE AS REQUIRED." A PREVENTIVE MAINTENANCE PROGRAM, FOLLOWING THE RECOMMENDATIONS IN THE SERVICE MANUAL, WOULD MITIGATE THE OCCURRENCES OF THE CALF SUPPORT BALL JOINT BECOMING LOOSE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES DURING A DELIVERY, THE LITHOTOMY POLE BALL JOINT CLAMP BECAME LOOSE AND THE PT'S LEG FELL ONTO THE MIDWIFE, CAUSING INJURY TO THE MIDWIFE'S SHOULDER. THE MIDWIFE WENT TO THE ACCIDENT AND EMERGENCY AND WAS OFF WORK MORE THAN (B)(6). THE ACCOUNT STATED THAT THE BALL JOINT CLAMP ON OTHER LITHOTOMY POLES FOR THIS TYPE OF BED APPEAR TO BECOME LOOSE VERY EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 4 BIRTHING BED HDD HILL-ROM INC 3700B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK