UNO 102 EE
Report
- Report Number
- 8030916-2025-00020
- Event Type
- Malfunction
- Date Received
- February 5, 2025
- Date of Event
- January 14, 2025
- Report Date
- March 10, 2025
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10-MAR-2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
UNO 102 MOBILE LIFT HAS ELECTRIC RAISING AND LOWERING OF THE LIFT ARM. UNO MOBILE LIFT IS INTENDED MAINLY FOR USE IN POST ACUTE CARE FACILITIES LIKE NURSING HOMES AND OTHER CARE HOMES IN THE MOST COMMON LIFTING SITUATIONS, FOR INSTANCE, TRANSFERS BETWEEN BED AND WHEELCHAIR, TO AND FROM TOILET AND FOR LIFTING TO AND FROM THE FLOOR. UNO MOBILE LIFT HAS THREE ALTERNATIVE HEIGHT SETTINGS, IN ORDER ALWAYS TO PROVIDE THE OPTIMUM LIFTING HEIGHT. UNIVERSAL SLINGBAR CAN BE USED IN COMBINATION WITH LIKO SLINGS THAT ATTACH TO THE SLING BAR USING SLING LOOPS. LIKO´S UNIVERSAL SLING BARS ARE WITH TWO ASSEMBLY OPTIONS, FIXED ASSEMBLY OR WITH QUICK-RELEASE HOOK. THE DEVICE IFU STATES: "FOR TROUBLE-FREE USE, CERTAIN DETAILS SHOULD BE CHECKED BEFORE EACH USE. WHEN USING A QUICK-RELEASE HOOK SYSTEM, CHECK THAT THE QUICK-RELEASE HOOK IS CORRECTLY FASTENED TO THE LIFT AND THE SLING BAR. BEFORE LIFTING, CHECK THAT THE LIFTING ACCESSORY HANGS VERTICALLY AND CAN MOVE FREELY." A BRUISE OR HEMATOMA IS AN INJURY TO TISSUES WITH SKIN DISCOLORATION AND WITHOUT BREAKAGE OF SKIN. BLOOD FROM THE BROKEN VESSELS ACCUMULATES IN SURROUNDING TISSUES, WHICH MAY PRODUCE PAIN, SWELLING, TENDERNESS, AND DISCOLORATION OF THE SKIN. MOST BRUISES/HEMATOMAS HEAL WITHOUT TREATMENT, COLD COMPRESSES MAY REDUCE BLEEDING IF APPLIED IMMEDIATELY AFTER THE INJURY AND MAY REDUCE SWELLING, DISCOLORATION, AND PAIN. IN THIS EVENT, THE PATIENT WAS NOTED TO HAVE SUSTAINED A BRUISE, WITH NO MEDICAL INTERVENTION REQUIRED, AND DID NOT SUSTAIN ANY FRACTURES FROM THE FALL. THE PATIENT DID NOT SUSTAIN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THUS A SERIOUS INJURY DID NOT OCCUR. PRELIMINARY IMAGES PROVIDED DO NOT IDENTIFY ANY ISSUES WITH THE SLING BAR, HOWEVER, FURTHER INVESTIGATION IS PENDING UPON RECEIPT OF DEVICE. A DEVICE MALFUNCTION OR USE ERROR CANNOT BE RULED OUT AT THIS TIME. HOWEVER, IF THE REPORT OF A DETACHMENT OF THE HOOK RESULTING IN A PATIENT FALL WERE TO RECUR, IT MIGHT LEAD TO THE OUTCOME OF A SERIOUS INCIDENT SUCH AS DEATH OR AN UNANTICIPATED SERIOUS DETERIORATION IN A PERSON'S STATE OF HEALTH. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
THE LIFT WAS EQUIPPED WITH A UNIVERSAL SLINGBAR AND Q-LINK 13. THE SLINGBAR AND Q-LINK 13 WERE RETURNED TO LULEA SITE AND INSPECTED. A VISUAL INSPECTION WAS PERFORMED. THE SLINGBAR WAS IN A GOOD CONDITION DESPITE BEING MANUFACTURED IN 2015. SCRATCHES AND DENTS OF MINOR CHARACTER WERE OBSERVED ON THE QUICK-RELEASE HOOK, BUT NOTHING THAT WOULD IMPACT THE SLINGBAR'S FUNCTIONALITY. NO DEVIATIONS WERE OBSERVED ON THE Q-LINK 13. A FUNCTIONAL TEST WAS PERFORMED BY ATTACHING THE SLINGBAR'S QUICK-RELEASE HOOK TO THE Q-LINK 13. THE TEST WAS SUCCESSFUL AS THE SLINGBAR COULD BE ATTACHED TO THE Q-LINK 13 WITHOUT ANY ISSUES. IT WAS DETERMINED THAT THE MOST LIKELY CAUSE OF THE INCIDENT WAS THE SLINGBAR HAD BEEN INCORRECTLY ATTACHED TO THE Q-LINK 13. ALTHOUGH THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THE REPORTED EVENT AND THE INVESTIGATION CONCLUDED THE INCIDENT WAS CAUSED BY USE ERROR, IF THE REPORTED INCIDENT WERE TO RECUR, IT COULD LEAD TO SERIOUS INJURY OR DEATH.
IT WAS REPORTED THAT DURING A TRANSFER USING A UNO 102 MOBILE LIFT, THE ¿LIFTING JUMPER (SLING BAR) INTO WHICH THE LOOPS OF THE HOIST ARE INSERTED, ¿LOOSENED¿ WHEN THE PATIENT¿S HUSBAND ATTEMPTED TO MOVE THE PATIENT, AND THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS REPORTED TO HAVE SUSTAINED BRUISING AT AN UNKNOWN LOCATION. IT WAS ALSO REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT THE PATIENT DID NOT SUSTAIN ANY FRACTURES. ADDITIONALLY, IT IS NOTED THAT THE PATIENT¿S HUSBAND ¿LIKELY ACCESSED THE QUICK RELEASE MECHANISM ON THE LIFTING JUMPER.
IT WAS REPORTED THAT DURING A TRANSFER USING A UNO 102 MOBILE LIFT, THE ¿LIFTING JUMPER (SLING BAR) INTO WHICH THE LOOPS OF THE HOIST ARE INSERTED, ¿LOOSENED¿ WHEN THE PATIENT¿S HUSBAND ATTEMPTED TO MOVE THE PATIENT, AND THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS REPORTED TO HAVE SUSTAINED BRUISING AT AN UNKNOWN LOCATION. IT WAS ALSO REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT THE PATIENT DID NOT SUSTAIN ANY FRACTURES. ADDITIONALLY, IT IS NOTED THAT THE PATIENT¿S HUSBAND ¿LIKELY ACCESSED THE QUICK RELEASE MECHANISM ON THE LIFTING JUMPER.
IT WAS REPORTED THAT DURING A TRANSFER USING A UNO 102 MOBILE LIFT, THE ¿LIFTING JUMPER (SLING BAR) INTO WHICH THE LOOPS OF THE HOIST ARE INSERTED, ¿LOOSENED¿ WHEN THE PATIENT¿S HUSBAND ATTEMPTED TO MOVE THE PATIENT, AND THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS REPORTED TO HAVE SUSTAINED BRUISING AT AN UNKNOWN LOCATION. IT WAS ALSO REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT THE PATIENT DID NOT SUSTAIN ANY FRACTURES. ADDITIONALLY, IT IS NOTED THAT THE PATIENT¿S HUSBAND ¿LIKELY ACCESSED THE QUICK RELEASE MECHANISM ON THE LIFTING JUMPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64596 | UNO 102 EE | LIFT PATIENT NON AC POWERED | FSA | BAXTER HEALTHCARE CORPORATION | 2010004 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A.| N/A.| N/A. |