BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V4

    MDR report key: 2110962 · Received March 28, 2011

    Report

    Report Number
    9681684-2011-00024
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ON-SITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH REP AFTER THE INCIDENT. HOWEVER, THE CUSTOMER HAD ALREADY PUT ANOTHER END STOPPER IN PLACE WHEN THE ARJOHUNTLEIGH REP WENT TO INSPECT THE TRACK, SO THE FACT THAT THERE WAS AN END STOPPER MISSING IS ONLY BASED ON THE ASSUMPTIONS OF THE CUSTOMER. THE ONLY WAY TO ASSESS THAT AN END STOPPER HAS NEVER BEEN INSTALLED IN A TRACK IS INDEED WHEN THERE IS NO TEETH MARK AND NO SCREW MARKS INSIDE THE TRACK, WHICH WAS NOT THE CASE WITH THIS EVENT. NEVERTHELESS, THE CEILING LIFT THAT WAS REPORTED TO HAVE FALLEN FROM THE TRACK WAS INSPECTED. THE REP NOTICED THAT THE PLASTIC CAB WAS BROKEN, WHICH COULD CONFIRM THE FALL. SINCE IT IS A TWO FUNCTIONS UNIT, WHICH MEANS THAT THE LATERAL MOTION IS NOT MOTORIZED, IT IS SUPPOSED THAT THE CAREGIVER WOULD HAVE LATERALLY PULLED THE CEILING LIFT UNTIL IT REACHED THE END OF THE TRACK AND FELL ON GROUND, AS THERE WAS NO END STOPPER TO PREVENT THE FALL. THE RECORDS INDICATE THIS INSTALLATION WAS COMMISSIONED IN 2006. SINCE THIS REPRESENTS ALMOST FIVE YEARS OF USE, IT CAN BE ASSUMED THERE WAS AN END STOPPER AT THE INITIAL INSTALLATION BECAUSE AN ADVERSE EVENT WOULD HAVE OCCURRED BEFORE. IN ADDITION, THE LAST SAFETY AUDIT WAS PERFORMED BY ARJOHUNTLEIGH IN 2010 AND THE SAFETY REPORT REVEALS THAT ALL THE POINTS OF THE AUDIT WERE COMPLIANT SO AN END STOPPER WAS PRESENT AT THIS TIME. AFTER THE EVENT, THE CUSTOMER AFFIRMED THAT HE REMOVED AN END STOPPER FROM ANOTHER ROOM, WHICH WAS UNUSED, TO INSTALL IT IN THE TRACK OF THE ROOM WHERE THE INCIDENT OCCURRED. BASED ON THE FACTS GATHERED, THE MOST PROBABLE ROOT CAUSE OF THIS INCIDENT IS THE FACILITY STAFF WOULD HAVE REMOVED THE END STOPPER FROM THE TRACK FOR MAINTENANCE AND DID NOT PUT IT BACK IN PLACE. THIS INDICATES A NEGLIGENCE TO FOLLOW THE SAFETY INSTRUCTIONS OF THE DEVICE INSTRUCTIONS FOR USE. IN ADDITION, IT WAS ALSO CONFIRMED THAT THERE WAS NOT ONE CEILING LIFT PER TRACK FOR ALL INSTALLATIONS IN THE FACILITY, WHICH COULD POINT TO THE FACT THAT THERE WAS NOT ENOUGH CEILING LIFTS FOR EACH INSTALLATION. THEREFORE, IT GIVES WEIGHT TO THE HYPOTHESIS IN WHICH CASE THE FACILITY STAFF WOULD MOVE THE CEILING LIFT FROM ROOM TO ROOM. THE CEILING LIFT HAD ALREADY BEEN REPAIRED AND TESTED BY THE REP WHO WENT ON-SITE. HE ALSO INSPECTED THE INSTALLATIONS AND INSTALLED AN END STOPPER IN THE ROOM WHERE THIS COMPONENT WAS MISSING. AS A PREVENTIVE ACTION, IT IS RECOMMENDED TO THE CUSTOMER TO RETRAIN THE MAINTENANCE PERSONNEL AND RECORD THIS RETRAINING. THE INSTRUCTIONS FOR USE PROVIDED AT THIS TIME SPECIFIES TO "ALWAYS REINSTALL THE RAIL END STOPPER (IF IT HAS BEEN REMOVED) AFTER SERVICING." A GENERAL END STOPPERS INSPECTION IS ALSO RECOMMENDED ON A YEARLY BASIS. IT IS ALSO RECOMMENDED TO THE CUSTOMER TO RETRAIN THE PERSONNEL THAT OPERATE THIS TYPE OF PRODUCT AND RECORD THIS RETRAINING. THE INSTRUCTIONS FOR USE PROVIDED AT THIS TIME SPECIFIES TO "MAKE SURE THAT RAIL END STOPPERS ARE IN PLACE BEFORE EVERY USE."

    Description of Event or Problem · 1

    THE CAREGIVER WAS MOVING A CEILING LIFT IN THE TRACK WHILE THERE WAS NO PT IN. THE CEILING LIFT WAS PULLED FAR ENOUGH TO HAVE THE DEVICE FALL OFF THE TRACK SINCE THERE WAS NO END STOPPER AT THIS END OF THE TRACK. NO INJURIES WERE SUSTAINED BY THE CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V4 MANUFACTURED CEILING FIXED CASSETTES FNG BHM MEDICAL INC. 9100201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other