MARISA
Report
- Report Number
- 3007420694-2022-00007
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- December 22, 2021
- Report Date
- February 16, 2022
- Manufacturer
- ARJO MED. AB LTD.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #(B)(4)). 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 #(B)(4) OR MEDIBO ((B)(4)) AND AH MAGOG ((B)(4)). 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 #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN NEXT REPORT.
PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #(B)(4)). 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 #(B)(4) OR MEDIBO ((B)(4)) AND AH MAGOG ((B)(4)). 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 #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN NEXT REPORT.
ARJO RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE HANGER BAR OF THE MARISA PASSIVE LIFT DETACHED FROM THE LIFT DURING A PATIENT TRANSFER. NO INJURIES WERE REPORTED. THE INSPECTION OF THE MARISA LIFT PERFORMED BY AN ARJO REPRESENTATIVE REVEALED THAT THE HANGER BAR COUPLING KIT WAS BROKEN AND SOME PARTS WERE MISSING. ARJO REPRESENTATIVE INDICATED THAT THE COUPLING COLLAR SNAPPED IN HALF AND THAT THE CAUSE OF THE REPORTED MALFUNCTION IS NORMAL WEAR AND TEAR. FOLLOWING THE INFORMATION COLLECTED THE MARISA LIFT WAS ABOVE 20 YEARS OLD AND WAS SUBJECTED TO WEAR AND TEAR DURING THIS TIME. THE LIFT WAS NOT UNDER ARJO SERVICE CONTRACT AND WAS SERVICING INTERNALLY BY THE CUSTOMER. TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION, THE DEVICE¿S OWNER IS OBLIGATED TO MAINTAIN THE DEVICE ACCORDING TO THE INSTRUCTION FOR USE (IFU). "THE EXPECTED OPERATIONAL LIFE OF THE ARJO LIFT IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE" THE INSTRUCTIONS FOR USE IN SECTION "CARE OF YOUR MARISA" RECOMMENDS TO PERFORM A DEVICE CHECKS ON A REGULAR BASIS: ¿ARJO RECOMMENDS THAT THE MARISA BE MAINTAINED AT REGULAR INTERVALS."; AT WEEKLY INTERVALS ARJO RECOMMEND TO CHECK THE OPERATIONAL FUNCTION OF THE DEVICE: "GENERAL LIFT CONDITION: CARRY OUT A GENERAL VISUAL INSPECTION OF ALL EXTERNAL PARTS, AND TEST ALL FUNCTIONS FOR CORRECT OPERATION, TO ENSURE THAT NO DAMAGE HAS OCCURRED DURING USE."; "WARNING: IF IN DOUBT ABOUT THE CORRECT FUNCTIONING OF THE MARISA, DO NOT USE IT AND CONTACT THE ARJO SERVICE DEPARTMENT." IN SUMMARY, THE MARISA LIFT WAS USED FOR RESIDENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY PLAYED A ROLE IN THE EVENT. THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. ARJO DECIDED TO REPORT THIS EVENT TO COMPETENT AUTHORITIES DUE TO THE RESIDENT FALL, WHICH COULD RESULT IN AN INJURY OCCURRENCE.
ARJO RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE HANGER BAR OF THE MARISA PASSIVE LIFT DETACHED FROM THE LIFT DURING A PATIENT TRANSFER. NO INJURIES WERE REPORTED.
ARJO RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE HANGER BAR OF THE MARISA PASSIVE LIFT DETACHED FROM THE LIFT DURING A PATIENT TRANSFER. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806203 | MARISA | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO MED. AB LTD. | KGA0200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Other |