ENCORE
Report
- Report Number
- 3007420694-2019-00058
- Event Type
- Malfunction
- Date Received
- April 9, 2019
- Date of Event
- March 10, 2019
- Report Date
- August 2, 2019
- Manufacturer
- ARJO MED. AB LTD.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
PLEASE NOTE THAT INFORMATION IN SECTION D3, F14 AND G1 REGARDING MANUFACTURER DETAILS HAS BEEN CORRECTED. IT WAS REPORTED TO THE ARJO REPRESENTATIVE THAT THERE WAS THE INCIDENT WITH THE INVOLVEMENT OF THE ENCORE ACTIVE FLOOR LIFT AND THE STANDARD WIPE DOWN STANDING SLING. DURING INITIAL PHASE OF TRANSFER, WHEN PATIENT WAS JUST RAISED FROM THE COMMODE, THE RESIDENT LOST BALANCE, FELL BACKWARDS TO THE FLOOR AND BANGED THE RIGHT SIDE OF THE HEAD TO THE MONITOR ARM. SLING DID NOT DETACH FROM THE LIFT SPREADER BAR. HOWEVER, IT WAS FOUND TO HAVE TWO STRAPS HOLDING THE SUPPORT BELT TORN FROM THE SLING'S WAIST PART. AS THE CONSEQUENCE OF THE EVENT PATIENT SUSTAINED MODERATE HEAD PAIN. AFTER THE EVENT ARJO REPRESENTATIVE PERFORMED EVALUATION OF THE ARJO SYSTEM: LIFT AND SLING. LIFT INVOLVED IN THE EVENT WAS WORKING CORRECTLY, ACCORDING TO MANUFACTURER'S SPECIFICATION. BESIDE THE FAILURE WHICH WAS INITIALLY REPORTED TO ARJO BY THE CUSTOMER (WELDING OF BOTH STRAPS WHICH HOLD THE POSITIONING SUPPORT BELT IN PLACE WERE DAMAGED) A GENERAL CONDITION OF THE SLING WAS GOOD (WITH NO SIGNS OF EXCESSIVE WEAR). THE SUPPORT BELT IS PART OF SLING WHICH IS ATTACHED TO THE MAIN SLING'S WAIST PART BY TWO STRAPS. PLEASE NOTE THAT THE SUPPORT BELT FUNCTION IS TO KEEP THE SLING IN THE CORRECT PLACE, IN ORDER TO ENSURE A CORRECT BODY POSTURE OF THE PERSON BEING TRANSFERRED. HOWEVER, THE ACTIVE SLING SUPPORT BELT IS NOT A PART OF THE SLING THAT IS SUPPOSED TO BEAR ANY WEIGHT. AFTER THE EVENT THE SLING IN QUESTION WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION TO ESTABLISH THE MAIN CAUSE OF THE FAILURE. A VISUAL AND DIMENSIONAL INSPECTION OF THE UNIT WAS PERFORMED TO VERIFY ACTUAL CONDITION OF THE SLING. WELDING FAILURE OF SUPPORT BELT BOTH STRAPS WAS FOUND. BASED ON THE EXPERTISE PERFORMED ON THE CLAIMED UNIT, THREE MOST PROBABLE ROOT CAUSES OF THE INCIDENT WERE IDENTIFIED: 1) MATERIAL ISSUES - ALL CRITICAL DIMENSIONS OF THE UNIT WERE MEASURED (LENGTH, WIDTH AS WELL AS AN ENVELOPE LENGTH) AND FOUND TO MEET THE CRITERIA OF MANUFACTURING SPECIFICATION FOR THE WIPE DOWN MATERIAL; ANY MATERIAL DEFECTS HAVE BEEN IDENTIFIED. 2) INCORRECT PARAMETERS USED IN THE MACHINE APPLICABLE DURING THE WELDING OPERATION 3) INCORRECT ADHERENCE OF THE LOOPS TO THE BODY OF THE UNIT AFTER THE WELDING PROCESS (NOT STRONG ENOUGH TO REMAIN WELDED DURING ITS USE) - THE INVOLVED WIPE DOWN STANDING SLING (MODEL KKA5420-L) WAS MANUFACTURED IN MARCH 2018, AND WAS IN USE FOR OVER A YEAR. ONLY ONE OTHER COMPLAINT PRESENTING SIMILAR NATURE OF WELDING ISSUE OF STRAPS HOLDING THE SUPPORT BELT ON ARJO WIPE DOWN SLING WHILE USING ENCORE DEVICE HAVE BEEN REPORTED. IN REGARDS TO THE COLLECTED INFORMATION, NONE OF THE PRESENTED ABOVE HYPOTHESES COULD HAVE BEEN CONFIRMED WITH A CERTAINTY. WHEN THE DEVICE IS USED ACCORDING TO THE LABELLING THE PERSON TO BE RAISED TO STAND WITH THE ACTIVE LIFT NEEDS: A) TO BE EVALUATED TO BE SUITED BEFORE USING AN ACTIVE LIFT. IT IS IN THE INTENDED USE OF ACTIVE LIFTS THAT THERE SHOULD BE AMPLE MUSCULATURE, SHOULDER MOVEMENT AND OVERALL HEALTH AND STRENGTH . B) TO BE LIFTED ACCORDING TO PROCEDURE : FEET ON THE FOOTPLATE (SUPPORT 1), KNEES AGAINST THE PRO-ACTIVE KNEE SUPPORTS (SUPPORT 2), UNDER ARMS ON THE ARC REST SUPPORT AND HANDS ON THE HANDGRIPS (SUPPORT 3) AND MOST IMPORTANTLY, SLING IN THE LOWER BACK, WITH THE CHEST STRAP FITTED SNUGLY TO MAKE SURE THAT THE SLING STAYS IN PLACE IN THE LOWER BACK. WHEN THE PERSON WOULD HAVE BEEN LIFTED WITH ENCORE ACTIVE LIFT AND WHEN THE LABELLING IS FOLLOWED, IT IS VERY UNLIKELY TO PATIENT DROP OR OTHER ADVERSE EVENT DURING THE TRANSFER OF THE PATIENT WITH THE SLING, EVEN WHEN THE "WIPEDOWN" SLING WITHOUT CHEST BELT WILL BE USED. THIS WAS CONFIRMED BY OUR SIMULATIONS. THREE TESTS WERE PERFORMED WITHOUT USING CHEST BELT WHICH SHOULD NORMALLY BE PLACED AROUND THE PERSON. DURING THOSE TESTS THE FOLLOWING SEQUENCE OF MULTIPLE USE ERRORS WAS FOUND AS A POSSIBLE ROOT CAUSE OF PERSON FULL DROP OUT OF THE SLING: - THE PERSON IS NOT CORRECTLY EVALUATED TO BE SUITED FOR TRANSFER FOR SARA PLUS ACTIVE LIFT (THE ONE WHICH IS NOT ABLE TO BEAR THE WEIGHT), - THE "WIPEDOWN" SLING WITHOUT THE CHEST BELT IS USED OR THE "WIPEDOWN" SLING WITH RIPPED BOTH STRAPS/LOOPS KEEPING THE BELT IN PLACE IS USED, - THE PERSON'S ARMS ARE NOT KEEPING UP. BASED ON THE SIMULATIONS WE CAN CONCLUDE THAT ADVERSE EVENT IS MOST LIKELY TO APPEARS WHEN THE PATIENT IS NOT SUITED FOR TRANSFER WITH SARA PLUS ACTIVE LIFT EVEN IF THE SLING IS USED WITHOUT THE CHEST BELT. THE REPORT CLEARLY SHOWS THAT THE TENDONS AND THE SKELETAL SYSTEM OF THE PERSON BODY TAKES OVER THE WEIGHT OF THE PERSON. PATIENTS ARE STILL SUPPORTED AND SECURED BY THE PRO-ACTIVE KNEEPAD, FOOT SUPPORT, THE ARC REST SUPPORT AND HANDS PLACED ON THE HANDGRIPS AND THE SLING ON THE BACK. LACK OF THE CHEST STRAP (INNER BELT) CAN ONLY CAUSE DISCOMFORT. THIS IS RESULT OF THE SLING MOVEMENT UNDER PATIENT'S ARMS WHICH PUSH THE CLOTHING SLIGHTLY UPWARDS. ACCORDING TO THIS WE CANNOT EXCLUDE POSSIBILITY THAT AT THE TIME OF THE EVENT PATIENT WAS NOT SUITED FOR TRANSFER WITH ACTIVE LIFT. THE ACTIVE SLING MANUFACTURING SPECIFICATION AND INFORMATION PROVIDED ON THE LABEL, THE SLING SHOULD BE ABLE TO WITHSTAND THE WEIGHT OF 190 KG. PLEASE NOTE THAT THE PATIENT WEIGHT WAS 100 KG, SO THE RECOMMENDED LIMIT WAS NOT EXCEEDED. THE INSTRUCTION FOR USE (04.SG.00-INT1_2, OCTOBER 2014) FOR THE SARA PLUS ACTIVE SLINGS PROVIDES PATIENTS WITH A CRUCIAL INFORMATION: "MAKE SURE YOU HAVE A RESCUE PLAN READY IN CASE OF A RESIDENT EMERGENCY.". "DO NOT: - WASH WITH OTHER ITEMS THAT HAVE ROUGH SURFACES OR SHARP OBJECTS, - TUMBLE DRY, - USE ANY MECHANICAL PRESSURE, PRESSING OR ROLLING DURING THE WASHING AND DRYING PROCESS.". "THE EXPECTED SERVICE TIME OF ACTIVE SLING IS THE MAXIMUM PERIOD OF USEFUL LIFE. THE OPERATIONAL LIFE OF THE SLING IS DEPENDENT ON THE ACTUAL USE CONDITION. THEREFORE, BEFORE USE, ALWAYS MAKE SURE THAT THE SLING DOES NOT SHOW ANY SIGNS OF FRAYING, TEARING OR OTHER DAMAGE AND THAT THERE IS NO DAMAGE (I.E. CRACKING, BENDING, BREAKING). IF ANY SUCH DAMAGE IS OBSERVED, DO NOT USE THE SLING.". TO CONCLUDE, ARJO SYSTEM - ENCORE ACTIVE LIFT AND ACTIVE SLING WAS USED FOR PATIENT'S TREATMENT AND IN THAT WAY CONTRIBUTED TO THE ALLEGED EVENT. THERE WAS NO MALFUNCTION WITHIN THE LIFT FOUND BUT STRAPS HOLDING THE INNER BELT TORE FROM THE SLING'S WAIST PART AND FROM THAT PERSPECTIVE THE SYSTEM DID NOT MEET THE MANUFACTURER'S SPECIFICATION. THE EVENT WAS REPORTED DUE TO THE ALLEGATION OF PATIENT'S FALL AND CIRCUMSTANCES DURING THE RESIDENT TRANSFER WHICH MAY HAVE RESULTED IN A SERIOUS INJURY UPON REOCCURRENCE.
COLLECTING INFORMATION ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
THIS IS A FOLLOW-UP REPORT FOR THE ONE INITIALLY SENT ON (B)(6) 2019. PLEASE NOTE THAT SECTION H10 HAS BEEN UPDATED. THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#(B)(4)) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#(B)(4)).
THE SLING IN QUESTION HAS BEEN SENT TO THE MANUFACTURER (DOMINICAN REPUBLIC) FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
IT WAS REPORTED TO THE ARJO REPRESENTATIVE THAT THERE WAS THE INCIDENT WITH THE INVOLVEMENT OF THE ENCORE ACTIVE FLOOR LIFT AND THE STANDARD WIPE DOWN STANDING SLING. IT WAS REPORTED THAT DURING INITIAL PHASE OF TRANSFER, WHEN PATIENT WAS JUST RAISED, THE RESIDENT LOST THE BALANCE, FELL BACKWARDS TO THE FLOOR AND BANGED THE RIGHT SIDE OF THE HEAD TO THE MONITOR ARM. AS THE CONSEQUENCE OF THE EVENT PATIENT SUSTAINED MODERATE HEAD PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291174 | ENCORE | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO MED. AB LTD. | KKA5020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |