MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for VITAL SIGNS #9 ORAL AIRWAY (YELLOW CAP) manufactured by Vyaire Medical, Inc..
[134968163]
Upon extubation, an oral airway was placed. Simultaneously, the crna noted a loose piece of plastic at the top of the airway. When the crna attempted to remove the loose piece of plastic, the patient inhaled and sucked the piece of plastic to the back of her throat. The crna was able to remove the piece of plastic to prevent aspiration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083544 |
| MDR Report Key | 8292860 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-28 |
| Date of Event | 2019-01-24 |
| Date Added to Maude | 2019-01-31 |
| 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 |
| 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 | VITAL SIGNS #9 ORAL AIRWAY (YELLOW CAP) |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2019-01-29 |
| Lot Number | 0001199122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-29 |