SLINGS, CLIP
Report
- Report Number
- 3007420694-2017-00017
- Event Type
- Malfunction
- Date Received
- January 24, 2017
- Date of Event
- November 8, 2016
- Report Date
- February 25, 2017
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. Z O.O.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSIONS FROM INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION GATHERED, THE LEG CLIP OF THE SLING DETACHED FROM THE SPREADER BAR LIFT DURING TRANSFER OF RESIDENT PROCESS FROM THE WHEELCHAIR TO THE BED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CLIP DETACHMENT). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE RELATIVELY LOW AND SLIGHTLY DECREASING. BASED ON THE PHOTOGRAPHIC EVIDENCE, IT WAS INDICATED THAT THE SLING INVOLVED TO BE FITTED WITH "GREY" CLIPS. PRODUCTION OF SLINGS WITH GREY CLIPS HAS STOPPED SOME TIME AGO (BETWEEN 2005 -2006). FOLLOWING THE LIFT INSTRUCTION FOR USE (IFU) FOR THESE ITEMS THE SLING SHOULD BE DISCARDED AFTER TWO YEARS LIFETIME, OR BEFORE THAT, WHEN DAMAGED. THE SLING INVOLVED THEREFORE WAS SIGNIFICANTLY PAST ITS LIFETIME. THIS IS AN INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ADDITIONALLY, IT WAS FOUND THAT CLIPS INSERTS HAD POPPED OUT AND THEREFORE CAN BE SEEN AS HAVING BEEN DAMAGED. ALTHOUGH WE DO NOT BELIEVE THIS PLAYED A SIGNIFICANT ROLE IN THE EVENT BY ITSELF, THESE ARE INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ACCORDING TO THE ABOVE THE SLING AND THE LIFT WHICH WORK TOGETHER AS A SYSTEM WERE FOUND TO HAVE NOT BEEN TO SPECIFICATION WHEN THE EVENT TOOK A PLACE. IT CAN BE ESTABLISHED THAT THE SLING AND THE LIFT WERE BEING USED FOR PATIENT HANDLING BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. THE SLING INSTRUCTIONS FOR USE PROVIDED WITH SLING CONTAINS THE CRUCIAL INFORMATION: THE USEFUL LIFE EXPECTANCY OF THE ARJOHUNTLEIGH SLING IS APPROXIMATELY TWO YEARS. A SLING CLIP, ONCE CORRECTLY ATTACHED AND MONITORED TO STAY IN PLACE AS THE WEIGHT OF THE PERSON IN THE SLING IS GRADUALLY TAKEN UP, AS INDICATED TO BE REQUIRED IN THE LABELLING, IS LOCKED IN POSITION WITH THE WEIGHT OF THE PATIENT. IT IS NOT LIKELY TO COME OFF DURING ON-LABEL USE. BASED ON PRODUCT KNOWLEDGE AND PREVIOUSLY MADE SIMULATIONS THIS THEN LEAVES OPEN A TWO POSSIBLE SEQUENCES OF EVENT: 1) BASED ON RECEIVED INFORMATION IT IS CLEAR THAT THE PERSON WAS LIFTED FROM SEATED POSITION. FROM SIMULATIONS, WE KNOW THAT IN THE SITUATION, WHEN THE CLIP IS NOT ATTACHED AND UNDER TENSION WITH THE WEIGHT OF THE PERSON IN THE SLING FROM THE START, A DROP WILL BE IMMEDIATE. IF THE LABELLING IS FOLLOWED THERE CAN BE NO ISSUE. HOWEVER, IT IS POSSIBLE FOR THE CAREGIVERS TO NOT HAVE FOLLOWED THE LABELLING AND NOT CHECKED THE CLIPS ARE CORRECTLY ATTACHED AND REMAIN IN TENSION AS THE WEIGHT OF THE RESIDENT IS GRADUALLY TAKEN UP. THE USER IS OBLIGED TO MONITOR THE CLIPS BECOMING UNDER TENSION WHEN THE WEIGHT OF THE PATIENT IS GRADUALLY BEING LOADED ON. 2) WHEN A TRANSFER OCCURS FROM THE WHEELCHAIR TO THE BED, THIS MEANS AT SOME POINT THERE MUST BE A REPOSITIONING FROM SEATED TO HORIZONTAL POSITION, TO PLACE THE PERSON IN THE BED CORRECTLY. ALSO THIS MEANS THAT THE RESIDENT MUST BE TURNED IN THE CORRECT DIRECTION. WHEN (A) THE CLIP WAS IN PLACE AND (B) IT WAS LOCKED IN POSITION BY THE WEIGHT OF THE PERSON IN THE SLING (THEREFORE NOT LIKELY TO COME OFF BY ITSELF), FROM PREVIOUS SIMULATIONS, WE HAVE BEEN ABLE TO ESTABLISH THAT THE MOSTLY LIKELY WAY TO DETACH A CLIP FROM THAT SITUATION, IS THAT THE CAREGIVER USED THE STRAP ON TOP OF THE CLIP - WHICH IS THERE TO DETACH THE CLIP AFTER THE TRANSFER HAS ENDED - TO MOVE AND TURN THE SPREADER BAR INTO POSITION SO THAT THE PERSON IN THE SLING WAS ALIGNED WITH THE BED. IN DOING SO, WHEN PULLING THE STRAP HARD ENOUGH IT CAN BE JOLTED LOOSE FROM THE SPREADER BAR, THE RESIDENT WEIGHT WILL COME ON IT AND IT WILL BE VERY HARD TO HOLD. THE SLING INSTRUCTION FOR USE (IFU) CURRENTLY USED CONTAINS CRUCIAL INFORMATION: "TO AVOID INJURY TO THE RESIDENT, PAY CLOSE ATTENTION WHEN LOWERING OR ADJUSTING THE SPREADER BAR." "TO AVOID THE RESIDENT FROM FALLING, MAKE SURE THAT THE SLING ATTACHMENTS ARE ATTACHED SECURELY BEFORE AND DURING THE LIFTING PROCESS." CONSEQUENTLY TO THE ABOVE, WE COME TO THE CONCLUSION THAT THE EVENT WAS MOST LIKELY CAUSED BY USE ERROR, BASED ON THE CUSTOMER INFORMATION AND THE SIMULATIONS PERFORMED PREVIOUSLY BASED ON EARLIER INCIDENTS. THE LABELLING FOR THE LIFT DEVICE INDICATES THE SYSTEM SHOULD BE USED BY TRAINED PERSONNEL THAT ARE AWARE OF THE IFU CONTENTS. NOTE THAT THE CUSTOMER WAS VISITED AND INTERVIEWED BY A LOCAL ARJOHUNTLEIGH REPRESENTATIVE. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.
ON 27 DECEMBER 2016 ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING THE TRANSFER OF RESIDENT FROM CHAIR TO BED, LEG CLIP OF SLING DETACHED FROM SPREADER BAR OF LIFT AND RESIDENT FELL ON THE FLOOR. NO RESIDENT INJURY WAS REPORTED AS CONSEQUENCES. THERE WAS ONLY INDICATION OF PAIN AT THE KNEE, HOWEVER, THERE WAS NOT CERTAINTY IF IT WAS RELATED TO THE FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58129 | SLINGS, CLIP | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJOHUNTLEIGH POLSKA SP. Z O.O. | MAA4000M-XL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |