MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for ALL ORTHOPEDI APPLIANCES UNKNOWN manufactured by Kirshner Medical Corporation.
[2444]
Patient placed in posey vest and soft wrist restraints. Patient found by nurse in contorted position between bed and siderails without pulse or respirations. Patient had do not resuscitate order on chart due to terminal status. Medical examiner notified and determined cause of death to be positional aphyxia. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not 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. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: failure to follow instructions. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2928 |
| MDR Report Key | 2928 |
| Date Received | 1992-07-22 |
| Date of Event | 1992-02-05 |
| Date Facility Aware | 1992-02-05 |
| Date Reported to Mfgr | 1992-02-21 |
| Date Added to Maude | 1993-04-01 |
| 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 | ALL ORTHOPEDI APPLIANCES |
| Generic Name | POSEY VEST RESTRAINT |
| Product Code | KID |
| Date Received | 1992-07-22 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2744 |
| Manufacturer | KIRSHNER MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-07-22 |