BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 1221513 · Received November 5, 2008

    Report

    Report Number
    9617021-2008-00042
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    July 30, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PICTURES OF THE SLING SHOWED DAMAGE SIMILAR TO WHAT IS FOUND WHEN A CLIP HAS BEEN OVERLOADED. THIS TYPE OF CLIP HAS A LOAD CAPACITY OF AT LEAST 225KG. THIS TYPE OF SLING HAS A TYPICAL SAFE WORKING LOAD A WEIGHT THAT IS PARTITIONED OVER FOUR CLIPS, WHICH LEAVES A CONSIDERABLE SAFETY MARGIN. THE CLIP BROKE IMMEDIATELY AFTER THE PATIENT WEIGHT WAS APPLIED; THE PATIENT WAS ONLY FIVE INCHES OFF THE FLOOR. A TEST WAS CARRIED OUT FOLLOWING A PREVIOUS SIMILAR INCIDENT WITH SIMILAR OUTCOME TOWARDS THE CLIP. THE TEST CONCLUDES WITH THE POSSIBILITY THAT THE CLIP BECAME SOMEHOW STUCK UNDER THE LIFT. THIS, OR OTHER INSTANCES WHERE THE CLIP WAS SUBJECTED TO MECHANICAL OVERLOAD BEFORE THE ACTUAL INTENDED USE WHERE IT FAILED, APPEAR ALSO TO BE POSSIBLE. (TYPICAL EXAMPLE IS THE WASHING AND DRYING PROCESS). BASED ON A RECENT OVERVIEW OF CLIP BREAKAGE INCIDENTS AS RECORDED BY THE MANUFACTURER, IT COULD BE CONCLUDED THAT THE ROOT CAUSE FOR CLIP BREAKAGE (IN THOSE CASES) IS THAT THE CLIP WAS EXPOSED TO EXTREME STRESS FROM AN OUTSIDE SOURCE, SUCH AS A DRYING PRESS, BEFORE THE INTENDED USE TOOK PLACE. BEGINNING THE INTENDED USE (PATIENT TRANSFER) IN A DEFORMED AND DAMAGED STATE, THE CLIPS SUBSEQUENTLY BREAKS. THE GUIDELINES FOR USE AS SUPPLIED WITH THE SLINGS SPECIFIES THAT NO MECHANICAL PRESSING IS TO BE USED IN THE WASHING PROCESS, AND THAT EACH CLIP SHALL BE CHECKED FOR DAMAGE BEFORE USE AND SHALL BE WITHDRAWN FROM USE IF DAMAGE IS FOUND. BASED ON THE EVALUATION OF THE INFORMATION GATHERED, THE MANUFACTURER CANNOT COME, WITH CERTAINTY, TO A CONCLUSION OF WHAT HAS CAUSED THE ALLEGED BREAK OF THE CLIP. HOWEVER, THE ACCUMULATED KNOWLEDGE ON CLIP BREAKAGE TO DATE, AS DESCRIBED ABOVE, AND THE FACT THAT THE CLIP BROKE SOON AFTER THE PATIENT'S WEIGHT WAS APPLIED, POINTS TOWARDS THE CLIP BEING IN A DAMAGED STATE BEFORE USE, DUE TO THE GUIDELINES FOR USE OF THE SLING NOT BEING FOLLOWED. THE MANUFACTURER CANNOT COME TO A CORRECTIVE ACTION TOWARDS THE PRODUCT BASED ON THIS INVESTIGATION. HOWEVER, MONITORING OF COMPLAINT TRENDING AND INCIDENT VIGILANCE WILL CONTINUE FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT GOT UP DURING THE NIGHT TO USE THE BATHROOM AND FELL BESIDE THE BED. THE STAFF MEMBERS GOT THE LIFTER AND SLING TO GET THE CLIENT OFF THE FLOOR. WHEN THE RESIDENT WAS FIVE INCHES OFF THE FLOOR, THE SHOULDER CLIP ON THE SLING BROKE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA PATIENT LIFT FNG ARJO MED. AB LTD. KPBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR