MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-18 for CARDIAC CHAIR manufactured by Tempco.
[16365485]
Nursing assistant was moving table attached to cardiac chair. 5th digit, left hand entered small opoening between table and chair-rail, finger lacerated requiring (6) six suturesdevice not labeled for single use. Patient medical status prior to event: satisfactory 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, other, other, invalid data. Results of evaluation: design - human factors. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device permanently removed from service, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1130 |
| MDR Report Key | 1130 |
| Date Received | 1992-08-18 |
| Date of Report | 1992-07-28 |
| Date of Event | 1992-05-02 |
| Date Facility Aware | 1992-05-02 |
| Report Date | 1992-07-28 |
| Date Reported to FDA | 1992-07-28 |
| Date Added to Maude | 1992-08-25 |
| 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 |
| Generic Name | CARDIAC CHAIR |
| Product Code | BYN |
| Date Received | 1992-08-18 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1083 |
| Manufacturer | TEMPCO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-18 |