MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-06-20 for PATIENT TRANS NA:PATIENTTRANS manufactured by Invacare Taylor St.
[78016572]
Invacare's lawyer spoke with the patient's lawyer who stated the lift was identified as a hill-rom lift, the sling is reported to be an invacare device. The lawyer reported the sling ripped. Although in the documents the use of one caregiver instead of two is repeatedly identified as the cause of the incident. The model, age and manufacture of the sling is not available. The device was not returned and no return is expected. Based on available information the underlying cause could not be determined. If more information is received, the decision will be reevaluated. The user manual 1023891 rev-i page 5 states: invacare slings are made specifically for use with invacare lifts. For the safety of the patient, do not intermix slings and lifts of different manufacturers.
Patient Sequence No: 1, Text Type: N, H10
[78016573]
Lawsuit received stating patient was being transferred with an unspecified patient lift when the patient fell and sustained a broken rib and other internal injuries which lead to the patient bleeding to death. No malfunction of the lift is reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2017-00010 |
| MDR Report Key | 6654305 |
| Report Source | OTHER |
| Date Received | 2017-06-20 |
| Date of Report | 2017-05-22 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PATIENT TRANS |
| Generic Name | SLING |
| Product Code | INE |
| Date Received | 2017-06-20 |
| Model Number | NA:PATIENTTRANS |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR ST |
| Manufacturer Address | 1200 TAYLOR ST ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-20 |