MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-04-14 for manufactured by .
[18719551]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030916-2008-00012 |
| MDR Report Key | 1032554 |
| Report Source | 08 |
| Date Received | 2008-04-14 |
| Date Mfgr Received | 2008-03-17 |
| Date Added to Maude | 2008-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATS LUNDIN |
| Manufacturer Street | NEDRE VAGEN 100 |
| Manufacturer City | LULEA 975 92 |
| Manufacturer Country | SW |
| Manufacturer Postal | 975 92 |
| Manufacturer Phone | 20474700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KME |
| Date Received | 2008-04-14 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 999656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-14 |