MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-03 for PATIENT VEST RESTRAINT UNKNOWN manufactured by Unknown.
[1118]
On 8/25/92 at park manaor health care center a 92-year-old white female who died in her bed as a result of apparently attempting to get out of her bed with a vest restraint on. The incident was investigated by the staff medical director, the city medical examiner, and the state medical examiner. It was determined that the cause of death was accidental traumatic asphyxiation caused by a vest restraintdevice not labeled for single use. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618 |
| MDR Report Key | 1618 |
| Date Received | 1992-11-03 |
| Date of Report | 1992-09-30 |
| Date of Event | 1992-08-25 |
| Date Facility Aware | 1992-08-25 |
| Report Date | 1992-09-30 |
| Date Reported to FDA | 1992-09-30 |
| Date Reported to Mfgr | 1992-09-30 |
| Date Added to Maude | 1992-11-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT VEST RESTRAINT |
| Generic Name | PATIENT RESTRAINT |
| Product Code | BRT |
| Date Received | 1992-11-03 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1541 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-11-03 |