MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for ETP5R-06A50 manufactured by Southmedic Incorporated.
[178369047]
Patient attempted to self-extubate. When entering pts room, endotracheal tube was found to still be partially in. When trying to advance the endotracheal tube, we were unable to remove the zip tie that was securing the endotracheal tube. Scissors were not readily available, and patient began to become cyanotic and endotracheal tube had to be pulled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9687097 |
| MDR Report Key | 9687097 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-11 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Added to Maude | 2020-02-10 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LNZ |
| Date Received | 2020-02-10 |
| Catalog Number | ETP5R-06A50 |
| Lot Number | W53132 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC INCORPORATED |
| Manufacturer Address | 2500 BEE CAVE ROAD BUILDING 1, SUITE 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |