MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-18 for * BBV03010 manufactured by Carefusion.
[3370451]
The external analyzer was found reading 21% with the ventilator set at 40%. Discovered when the clinician caring for the patient noted that the patient's oxygen saturation did not respond as anticipated with an increase in fio2. The vent was immediately discontinued from use and secured for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915259 |
| MDR Report Key | 2915259 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-11-28 |
| Date of Event | 2012-11-06 |
| Report Date | 2012-11-28 |
| Date Reported to FDA | 2012-12-18 |
| Date Added to Maude | 2013-01-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ANALYZER, GAS |
| Product Code | CCL |
| Date Received | 2012-12-18 |
| Model Number | BBV03010 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-18 |