MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for ENDOTRACHEAL TUBE DYND43080 manufactured by Medline Canada.
[183342963]
Pt suffered a code arrest from hypoxia as a result of the endotracheal tube being severely kinked above the cuff and unable to deliver volume. The pt had been found pulseless upon arrival to the emergency dept. Cpr was initiated and the pt was intubated at that time. Approx 5 hrs later, a leak was heard from the endotracheal tube and the pt was noticeably grasping for breath. During efforts to change the tube the pt went into full cardiac arrest and cpr was initiated. Efforts to change the tube and to revive the pt were successful. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093672 |
| MDR Report Key | 9818434 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 |
| Brand Name | ENDOTRACHEAL TUBE |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-10 |
| Model Number | DYND43080 |
| Catalog Number | DYND43080 |
| Lot Number | 59219010087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE CANADA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-10 |