MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for VITAL SIGNS A4G12XXX manufactured by Vyaire Medical, Inc..
[102468358]
Patient Sequence No: 1, Text Type: N, H10
[102468359]
After intubation of patient, it was found that the end tidal carbon dioxide (co2) was not capturing on the anesthesia machine. The doctor stated no recording on the monitor. The breathing circuit was checked and it was found that the curved connector on the breathing mask did not have a hole. The piece was switched and replaced with a new connector and the anesthesia monitor began reading the end tidal co2. Rn notified the charge nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7340829 |
| MDR Report Key | 7340829 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-03-05 |
| Report Date | 2018-03-07 |
| Date Reported to FDA | 2018-03-07 |
| Date Reported to Mfgr | 2018-03-07 |
| Date Added to Maude | 2018-03-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | VITAL SIGNS |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT |
| Product Code | BSJ |
| Date Received | 2018-03-15 |
| Catalog Number | A4G12XXX |
| ID Number | SIZE 120IN 3M |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |