MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for WAIST AND CHEST JACKET 3138 UNKNOWN manufactured by J.t. Posey Company.
[2421]
Patient confused: posey vest applied to keep patient from climbing out of bed. Patient found against bed rail with restraint tight against neck. Initially had no pulse or respirations, code called. Patient responded and transferred to icu. Next day patient was awake and appeared to be functioning at the level he was prior to the code. Device 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 used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3473 |
| MDR Report Key | 3473 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-07-10 |
| Date of Event | 1992-03-12 |
| Date Facility Aware | 1992-03-12 |
| Report Date | 1992-07-10 |
| Date Reported to Mfgr | 1992-07-10 |
| Date Added to Maude | 1993-04-20 |
| 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 | WAIST AND CHEST JACKET |
| Generic Name | POSEY VEST |
| Product Code | MHZ |
| Date Received | 1992-07-31 |
| Model Number | 3138 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3216 |
| Manufacturer | J.T. POSEY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-31 |