MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-02 for ONE WAY VALVE manufactured by Ge.
[54289070]
Manual ventilation of a patient in mri suite with ambu bag, corrugated tubing and one way valve. The one way valve assemble between the corrugated tubing and the endotracheal tube did not allow for exhalation. The patient experienced cardiopulmonary arrest and expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5935417 |
| MDR Report Key | 5935417 |
| Date Received | 2016-09-02 |
| Date of Report | 2016-09-02 |
| Date of Event | 2016-08-24 |
| Date Facility Aware | 2016-08-24 |
| Report Date | 2016-09-02 |
| Date Added to Maude | 2016-09-08 |
| 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 | 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 | 0 |
| Brand Name | ONE WAY VALVE |
| Generic Name | ONE WAY VALVE |
| Product Code | BYP |
| Date Received | 2016-09-02 |
| Device Availability | Y |
| Device Age | 20 NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-09-02 |