FDA Adverse Event
Malfunction
Summary report: N
LIKORALL
MDR report key: 1945982
·
Received December 17, 2010
Report
- Report Number
- 8030916-2010-00069
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- May 3, 2009
- Report Date
- May 4, 2009
- Manufacturer
- LIKO AB
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.
Description of Event or Problem · 1
THE LIKORALL BECAME DETACHED FROM THE RAIL. IT FELL DOWN DURING THE LIFT. THE PT FELL BACK ONTO THE BED. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIKORALL | AC POWERED PATIENT LIFT | FNG | LIKO AB | LIKORALL 240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |