BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON TABLE

    MDR report key: 454458 · Received April 16, 2003

    Report

    Report Number
    MW1028158
    Event Type
    Malfunction
    Date Received
    April 16, 2003
    Date of Event
    March 27, 2003
    Report Date
    April 7, 2003
    Manufacturer
    ORTHOPEDIC SYSTEMS INC.
    Product Code
    FWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING PREPARED TO UNDERGO MULTIPLE SPINAL PROCEDURES. ONCE THE PT WAS PLACED IN THE PRONE POSITION ON THE JACKSON TABLE, AND THE TABLE WAS LOCKED INTO PLACE, AND DURING THE TIME THAT THE PT WAS BEING POSITIONED, THE BED'S LOCKING SWIVEL BROKE LOOSE, NEARLY CAUSING THE PT TO FALL OFF OF THE FRAME. SEVERAL MEMBERS OF THE NURSING STAFF IMMEDIATELY CAUGHT THE PT, WHO WAS NOT HARMED IN ANY WAY. A NEW JACKSON TABLE WAS BROUGHT INTO THE OPERATIVE FIELD, AND IT PERFORMED APPROPRIATELY WELL. THE PT WAS NOT ADVERSELY IMPACTED BY THIS EVENT, NOR WAS THE SURGERY EXTENDED FOR ANY APPRECIABLE AMOUNT OF TIME.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 6/30/03: IN THE MDR FILED ON THIS INCIDENT, THE USER FACILITY INDICATED THAT "THE BED'S LOCKING SWIVEL BROKE LOOSE, NEARLY CAUSING THE PT TO FALL OFF THE FRAME". IT ALSO INDICATES THAT "THE TABLE WAS LOCKED INTO PLACE". IF THIS WAS THE CASE, THE FAILURE OF THIS COMPONENT WOULD NOT CONSTITUTE A SAFETY ISSUE OF THE PT. THE OSI USER GUIDE CLEARLY EXPLAINS THE PROCEDURE WHERE BOTH THE 180 DEGREE ROTATION LOCK (COMMONLY KNOWN AS THE HEAD END BRAKE) AND THE ROTATION SAFETY LOCK (COMMONLY KNOWN AS THE FOOT END BRAKE) BE ENGAGED PRIOR TO PT TRANSFER. THESE LOCKS PROVIDE A REDUNDANT LOCKING CONDITION SO THAT IF THESE TWO LOCKS ARE ENGAGED, THERE IS NO POSSIBILITY THAT THE TABLE CAN MOVE UNEXPECTEDLY AS THIS REPORT SUGGESTS. THIS IS TRUE EVEN IN THE CASE IF THE SCREW MENTIONED ABOVE FAILS. IN OTHER WORDS, THESE TWO REDUNDANT BRAKES WILL HOLD THE TABLE SECURE UNDER ANY FAILURE CONDITION. THE ONLY CONCLUSION THAT CAN BE DRAWN FROM THIS REPORT IS THAT THE USER DID NOT PROPERLY ENGAGE THE ROTATION SAFETY LOCK PRIOR TO PT TRANSFER. THE LOCKED CONDITION OF THESE BRAKES IS INDICATED BY TWO INDICATOR LIGHTS AT THE HEAD END OF THE TABLE. THE PROCEDURE STATES THAT A PT SHOULD NOT BE TRANSFERRED TO THE TABLE UNLESS BOTH OF THESE LIGHTS ARE ILLUMINATED. CO MUST CONCLUDE THAT THE USER OPERATED THE DEVICE IMPROPERLY AND THE ONLY REASON THAT THE TABLE MOVED IS BECAUSE IT WAS NOT LOCKED. IN REGARD TO THE FAILED SCREW, IT HAS BEEN REPAIRED AND THE TABLE IS CONFIRMED TO BE FUNCTIONING CORRECTLY. IN ADDITION, AN OSI REP HAS VISITED THIS FACILITY TO RE-EDUCATE THEM ON PROPER USE OF THE TABLE. THERE WERE NO FAILURES REPORTED OF THE POWER SOURCE OF THE TABLE AND THIS IS NOT A LIFE-SUSTAINING DEVICE, SO THERE IS NO INFO TO REPORT IN THIS REGARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON TABLE SURGICAL SPINAL TABLE FWY ORTHOPEDIC SYSTEMS INC. 5892 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR