FDA Adverse Event
Other
Summary report: N
8030916-2008-00012
MDR report key: 1032554
·
Received April 14, 2008
Report
- Report Number
- 8030916-2008-00012
- Event Type
- Other
- Date Received
- April 14, 2008
- Product Code
- KME
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IT WAS DISCOVERED DURING THE ON-SITE INVESTIGATION THAT THE SHEET HAD BEEN INCORRECTLY USED DURING THE PT LIFT. ONLY THE TWO UPPER PAIR OF STRAPS WERE USED, INSTEAD OF THREE TO FOUR WHICH IS RECOMMENDED IN THE INSTRUCTION GUIDE. THE LIFTING STRAPS WERE TURNED TOWARDS THE PT, RATHER THAN AWAY FROM THE BODY AND THE SHEET WAS PULLED DURING THE TRANSFER PROCESS, RATHER THAN USING THE SHEET STRAPS. PICTURES OF THE SHEET SHOW NO DIVERGENCE FROM SPEC. THE PROBLEM COULD NOT BE RECREATED WHEN A NEW SHEET WAS USED ACCORDING TO THE INSTRUCTION GUIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |