MARISA
Report
- Report Number
- 3007420694-2016-00217
- Event Type
- Injury
- Date Received
- October 18, 2016
- Date of Event
- September 15, 2016
- Report Date
- September 19, 2016
- Manufacturer
- ARJO MED AB LTD
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT THE PATIENT FELL FROM THE SLING DURING TRANSFER USING MARISA LIFT AND SLING. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (SLID OUT OF SLING). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE RELATIVELY LOW AND STABLE. THE LIFT (MARISA) AND THE SLING WHICH WORK AS A SYSTEM WERE INSPECTED AND FOUND TO HAVE MALFUNCTIONED (NOT TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. NO MALFUNCTIONS WERE INDICATED REGARDING THE SLING. ON SITE INSPECTION FOUND HANGER BAR OF THE LIFT NOT ENOUGH FRICTION. PLEASE NOTE THAT NO MALFUNCTIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT, BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. FROM OUR PRODUCT KNOWLEDGE IN PART GAINED FROM REVIEW OF PREVIOUS COMPLAINTS AS WELL AS FROM SIMULATION PERFORMED, THERE IS NO POSSIBILITY TO SLIDE OUT OF THE SLING DURING THE ON LABEL USE. THERE ARE FEW ELEMENTS WHICH COULD CONTRIBUTE TO A PERSON SLIDING OUT FROM THE SLING, AS FOLLOWING: 1. A SLING BEING USED THAT IS OF A VERY INAPPROPRIATE SIZE (SEVERAL SIZES OFF). 2. AN OBVIOUS WRONG APPLICATION OF THE SLING (E.G.: SLING USED UPSIDE DOWN, WRONG TYPE OF THE SLING USED, WRONG POSITION OF THE RESIDENT/PATIENT ARMS). 3. A SLING CLIP DETACHING OR NOT BEING ATTACHED TO THE LIFT DEVICE BEFORE STARTING THE TRANSFER. 4. A SLING BEING USED WITH NO PLASTIC SUPPORT STAYS/STIFFENERS INSIDE THE HEAD SECTION OF THE SLING, AND THE PERSON BEING POSITIONED INTO THE MOST HORIZONTAL POSITION. FOLLOWING THE INFORMATION RECEIVED AND DOCUMENTED IN THE COMPLAINT FILE, THE SLING INVOLVED IN THE EVENT "SLING WAS NOT SIZED CORRECTLY". THEREFORE, IT APPEARS LIKELY THAT SCENARIO 1 DESCRIBED ABOVE IS MOST RELATED TO THE PATIENT'S FALL. THE MARISA INSTRUCTION FOR USE (IFU) CONTAINS IMPORTANT INFORMATION: "WARNING IT IS ADVISABLE FAMILIARISE YOURSELF AND UNDERSTAND THE OPERATION OF THE VARIOUS CONTROLS AND FEATURES OF THE MARISA AND ENSURE THAT ANY ACTION OR CHECK SPECIFIED IS CARRIED OUT BEFORE COMMENCING TO LIFT A PATIENT." THE PASSIVE CLIP SLING INSTRUCTION CURRENTLY USED CONTAINS THE FOLLOWING :"WARNING TO AVOID THE RESIDENT FROM FALLING, MAKE SURE TO SELECT THE CORRECT SLING SIZE ACCORDING TO THE IFU". THE LIFT (MARISA) AND THE SLING WHICH WORK AS A SYSTEM WERE INSPECTED AND FOUND TO HAVE MALFUNCTIONED (NOT TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. NO MALFUNCTIONS WERE INDICATED REGARDING THE SLING AND THAT WAY CONTRIBUTED THE EVENT THAT IN OUR EVALUATION WAS CAUSED BY THE USER NOT FOLLOWING THE IFU, DUE TO LACK OF AWARENESS OF THE IFU CONTENTS - DURING USE WITH A PATIENT. NOTE THAT THE CUSTOMER WAS VISITED AND INTERVIEWED BY A LOCAL ARJOHUNTLEIGH REPRESENTATIVE. THE TRAINING PROVIDED FOR THE CAREGIVERS WAS FOUND TO BE INSUFFICIENT AND IN THAT FACT ALL USERS MUST BE TRAINED AS PER IFU. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE AND CHECK SLING BEFORE TRANSFER. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.
ON 19 SEPTEMBER 2016 ARJOHUNTLEIGH WAS INFORMED THAT DURING THE LIFTING OF RESIDENT FROM WHEELCHAIR WITH MARISA LIFT AND SLING, THE RESIDENT SLIPPED OUT OF SLING AND FELL ON THE FLOOR. AS A CONSEQUENCE, RESIDENT SUSTAINED A HEAD INJURY. IT WAS REPORTED THAT NOT CORRECT SIZE OF SLING HAS BEEN USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 689596 | MARISA | MARISA | FSA | ARJO MED AB LTD | KGA0200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |