FDA Adverse Event
Malfunction
Summary report: N
MARISA
MDR report key: 1761028
·
Received July 7, 2010
Report
- Report Number
- 9611530-2010-00032
- Event Type
- Malfunction
- Date Received
- July 7, 2010
- Date of Event
- June 16, 2010
- Report Date
- June 18, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. TRACK WISE ID.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER 2010-(B)(6): THE RESIDENT WAS BEING TRANSFERRED FROM BED TO A CHAIR. SHE WAS POSITIONED IN SLING AND CLIPPED SLING TO LIFT. NURSE STARTED TO RAISE THE LIFT AND THE SHOULDER CLIP BECAME DE-ATTACHED AND RESIDENT SLID OUT OF SLING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARISA | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | KGA0200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |