MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for VMAX manufactured by Carefusion 207, Inc. Dba Carefusion.
[58381151]
Patient Sequence No: 1, Text Type: N, H10
[58381152]
Oxygen sensor not working correctly resulting in erroneous results. Three patients needed to be retested. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6056949 |
| MDR Report Key | 6056949 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-09-12 |
| Date Reported to FDA | 2016-09-12 |
| Date Reported to Mfgr | 2016-09-12 |
| Date Added to Maude | 2016-10-26 |
| 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 | VMAX |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-10-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 207, INC. DBA CAREFUSION |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-26 |