UNIVERSAL SLINGB 450 QRH
Report
- Report Number
- 8030916-2022-00032
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- May 20, 2022
- Report Date
- June 27, 2022
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
HILLROM IS IN THE PROCESS OF CONTACTING THE CUSTOMER FOR ADDITIONAL INFORMATION ON THE CIRCUMSTANCES THAT LEAD TO THE BROKEN SLINGBAR. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.
ADDITIONAL INFORMATION FROM THE CUSTOMER INFORMS THAT THE PATIENT WAS LIFTED WITH THE SLING. THE SLINGBAR BROKE WHEN THE PATIENT WAS CLOSE TO HER WHEELCHAIR. NO INJURY TO PATIENT. THE BROKEN SLINGBAR HAD BEEN DISCARDED BY THE CUSTOMER, BUT A PICTURE OF THE BROKEN COMPOSITE SLING BAR HOOK WAS PROVIDED. THE PICTURE SHOWS A FRACTURE IN THE COMPOSITE HOOK. THE FRACTURE HAS OCCURRED OUTSIDE OF THE PART ON THE HOOK WHERE THE LOOP OF THE SLING SHALL BE APPLIED. IF THE LOOP OF THE SLING IS APPLIED CORRECT, INSIDE THE HOOK AS INTENDED, THE LOAD FROM THE LOOP WILL LAY IN THE BOTTOM OF THE HOOK. THE FORCE ON THE SLINGBAR WILL THEN APPLY FROM ITS ATTACHMENT POINT ON THE LIFT OUT TO THE BOTTOM OF THE HOOK. SINCE THE FRACTURE ON THE HOOK IS FURTHER OUT ON THE HOOK IT CAN BE CONCLUDED THAT THE LOAD ON THE HOOK HAS NOT BEEN CENTERED CORRECT. THE UNIVERSAL SLINGBAR CAN BE USED IN COMBINATION WITH LIKO SLINGS THAT ATTACHES TO THE SLING BAR USING SLING LOOPS. LIKO´S UNIVERSAL SLING BARS ARE WITH TWO ASSEMBLY OPTIONS, FIXED ASSEMBLY OR WITH QUICK-RELEASE HOOK. HILLROM INVESTIGATION CONCLUDES THAT THE UNIVERSAL SLINGBAR WILL NOT BREAK IF IT IS USED AS INTENDED. THE UNIVERSAL SLINGBAR CAN HOLD THE LOAD IT IS DESIGNED FOR IF THE LOAD IS APPLIED ACCORDING TO INSTRUCTION FOR USE. TESTS DEMONSTRATE THAT THE COMPOSITE HOOKS ON THE UNIVERSAL SLINGBAR CAN WITHSTAND MORE THAN 780 KG LOAD UNTIL BREAKAGE. OUR INVESTIGATION FURTHER SHOWS THAT THE BREAKAGE OF THE COMPOSITE HOOK CAN OCCUR AT LOWER WEIGHT IF THE LOAD IS NOT CENTERED, THE LOAD IS APPLIED IN ONLY ONE HOOK OR THE LOAD IS NOT APPLIED INSIDE THE HOOK AS INTENDED. IN THE INSTRUCTION FOR USE FOR UNIVERSAL SLING BARS (7EN160185 REV 5), THE SAFETY INSTRUCTION SECTION STATES: - BEFORE LIFTING, ALWAYS MAKE SURE THAT THE SLING¿S STRAP LOOPS ARE CORRECTLY FASTENED TO THE SLING BAR HOOKS WHEN THE SLING STRAP IS EXTENDED, BUT BEFORE THE PATIENT IS LIFTED FROM THE UNDERLYING SURFACE. - FOR SAFETY, LOAD MUST BE APPLIED TO ALL SLING BAR HOOKS ON THE SLING BAR DURING THE LIFT! ALTHOUGH THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE REPORTED EVENT, THE REPORT OF THE SLING BAR HOOK BREAKING DURING PATIENT LIFT COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION. H3 OTHER TEXT : CUSTOMER DISCARDED THE BROKEN SLINGBAR.
THE CUSTOMER REPORTED THAT THE END OF THE SLINGBAR WAS BROKEN. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
THE CUSTOMER REPORTED THAT THE END OF THE SLINGBAR WAS BROKEN. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1846465 | UNIVERSAL SLINGB 450 QRH | LIFT, PATIENT, NON-AC-POWERED | FSA | LIKO AB | 3156085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |