MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-25 for BED AND SIDE RAILS 3080K=BED; 5000=RAILS manufactured by Smith & Davis Manufacturing Company.
[1755]
A female patient aged 47 was found caught between her bed and side rails. The alleged cause of death was positioning asphyxiation. Therefore, we beleive that the bed and side rails may have contributed to her death. Invalid data - regarding single use labeling of device. 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2396 |
| MDR Report Key | 2396 |
| Date Received | 1993-01-25 |
| Date of Report | 1992-12-10 |
| Date of Event | 1992-10-24 |
| Report Date | 1992-12-10 |
| Date Reported to FDA | 1992-12-10 |
| Date Reported to Mfgr | 1992-12-10 |
| Date Added to Maude | 1993-02-08 |
| 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 | BED AND SIDE RAILS |
| Product Code | FNK |
| Date Received | 1993-01-25 |
| Model Number | 3080K=BED; 5000=RAILS |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 2222 |
| Manufacturer | SMITH & DAVIS MANUFACTURING COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-01-25 |