BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 2910252 · Received November 23, 2012

    Report

    Report Number
    9681684-2012-00090
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS PERFORMED BY THE MANUFACTURER, INCLUDING A REVIEW OF THE TREND OF SIMILAR PROBLEM, HISTORY OF THE PRODUCT INVOLVED AND INFORMATION RELEASED ABOUT SEQUENCE OF EVENT. THERE HAVE BEEN THREE PREVIOUS SIMILAR EVENTS IN THE LAST FIVE YEARS, WHICH REPRESENTS A SIGNIFICANTLY LOW OCCURRENCE RATE WHEN COMPARED TO THE 86,302 INSTALLED BASES ON THE WORLDWIDE MARKET. NO RELEVANT INFORMATION WAS FOUND WHEN REVIEWING THE MANUFACTURING PROCESS AND OF THIS PRODUCT. IT MUST BE NOTED THAT THIS MODEL OF CEILING LIFT IS PACKAGED AT THE MANUFACTURING SITE WITHOUT SPREADER BAR, PART THAT MUST BE PURCHASED SEPARATELY. ADDITIONAL INFORMATION WAS GATHERED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. IT WAS MENTIONED THAT THE SPLIT RING, WHICH IS USED TO SECURE THE CLEVIS PIN OF THE SPREADER BAR ATTACHMENT FIXTURE, WAS MISSING. THE RETURN OF THE DEVICE TO THE MANUFACTURER WAS NOT DEEMED NECESSARY, AS THE COMPLAINT INVOLVES A MISSING COMPONENT WHICH COULD NOT BE FOUND AND THERE WAS NO OTHER ALLEGATION OF DEFICIENCY OF THE DEVICE OR ANY OF ITS COMPONENTS. BASED ON THE DESCRIPTION OF THE EVENT, IT IS CONCLUDED THAT THE SPREADER BAR DETACHED FROM THE CEILING LIFT, CAUSING THE DROP OF THE PATIENT TO THE FLOOR, DUE TO THE SPLIT RING THAT WAS MISSING. SINCE NO SPLIT RING WAS FOUND FOLLOWING THE EVENT, AND SINCE THE SPLIT RING IS NOT SOLICITED DURING USE, IT DOES NOT APPEAR LIKELY THAT THE SPLIT RING BROKE DURING USE. IT IS MOST LIKELY THAT THE SPLIT RING WAS NOT PROPERLY INSTALLED OR NOT INSTALLED AT ALL WHEN THE SPREADER BAR WAS RE-INSTALLED ON THE LIFT, OR THAT IT HAD BEEN REMOVED BY A PERSON FOR UNKNOWN REASON. THE ASSEMBLY OF THE SPREADER BAR TO THE CEILING LIFT IS NOT PERFORMED AT THE MANUFACTURING SITE AS BOTH ITEMS ARE SOLD APART; IT MUST BE PERFORMED BY THE CUSTOMER. THE CUSTOMER MAY ALSO CHANGE THE SPREADER BAR FROM ONE CEILING LIFT TO ANOTHER TO CHANGE THE ACCESSORY. IT APPEARS HIGHLY IMPROBABLE THAT THE SPLIT RING HAD BEEN ABSENT SINCE THE FIRST USE OF THE DEVICE. THERE ARE REQUIRED CHECKS IN THE DEVICE INSTRUCTIONS FOR USE (001.14150.33) THAT SHOULD HAVE PERMITTED TO DETECT THE PROBLEM BEFORE THE EVENT OCCURRED. THEREFORE, IT APPEARS LIKELY THAT A USER ERROR, MOST PROBABLY CAUSED BY A LACK OF TRAINING, CONTRIBUTED TO THE OUTCOME OF THE EVENT. NO TRAINING DATES OF THE STAFF INVOLVED COULD BE GIVEN. IT IS SUGGESTED TO REMIND THE FACILITY THAT STAFF SHOULD BE RETRAINED AGAINST THE DEVICE LABELING, WITH A SPECIAL ATTENTION TO THE RECOMMENDATIONS BELOW: ¿WARNING: BEFORE LIFTING THE RESIDENT [¿] MAKE SURE THAT THE SPREADER BAR IS CORRECTLY FIXED TO THE CEILING LIFT.¿ (P. 18). ¿WARNING: SPREADER BAR MUST ONLY INSTALLED BY A QUALIFIED PERSON.¿ (P. 17). ¿WARNING: BEFORE USING THE MAXI SKY 600 ALWAYS ENSURES THE STRAP ATTACHMENT PIN IS RE-FITTED CORRECTLY THROUGH THE SPREADER BAR SOCKET AND LIFT STRAP, AND THAT THE SECURING RING IS CORRECTLY INSERTED THROUGH THE HOLE IN THE PIN.¿ (P. 17). ¿DAILY CHECK LIST ¿ENSURE THAT THE SPLIT RING AND COTTER PINS THAT ATTACH THE SPREADER BAR TO THE STRAP ARE SECURED.¿ (P. 45).

    Description of Event or Problem · 1

    THE CAREGIVERS WERE LIFTING THE RESIDENT WHEN THEY REALIZED THAT THE CLEVIS PIN FROM THE SPREADER BAR ATTACHMENT WAS COMING OFF. THE SPREADER BAR BECAME DETACHED AND DROPPED WITH RESIDENT TO THE FLOOR. THE CAREGIVERS SUPPORTED THE RESIDENT AS MUCH AS POSSIBLE TO AVOID INJURIES. NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FSA ARJOHUNTLEIGH MAGOG INC. LD10200

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR