MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-17 for ENDOTRACHEAL TUBE (8 SIZE) manufactured by Mallinckrodt.
[18136333]
Et tube was being ventilated/ventilator servo 900c. Patient vomited while intubated and aspriated due to faulty cuff. Pt's condition now very poordevice 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. Results of evaluation: end of life - expected. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5173 |
| MDR Report Key | 5173 |
| Date Received | 1993-05-17 |
| Date of Report | 1993-05-04 |
| Date of Event | 1993-04-16 |
| Date Facility Aware | 1993-04-16 |
| Report Date | 1993-05-04 |
| Date Reported to Mfgr | 1993-05-04 |
| Date Added to Maude | 1993-06-29 |
| 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 | ENDOTRACHEAL TUBE (8 SIZE) |
| Product Code | LNZ |
| Date Received | 1993-05-17 |
| ID Number | 8.0 FR ET TUBE |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 4875 |
| Manufacturer | MALLINCKRODT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-05-17 |