MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-09 for MINI OX 3000 manufactured by .
[17971342]
Reported that analyzer fio2 was fluctuating and beeping. Respiratory therapist went into the room and it was found to be reading w/o any problems, but it was switched out as a precaution. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021713 |
| MDR Report Key | 2211456 |
| Date Received | 2011-08-09 |
| Date of Report | 2011-08-09 |
| Date of Event | 2011-08-09 |
| Date Added to Maude | 2011-08-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI OX 3000 |
| Generic Name | OXYGEN ANALYZER |
| Product Code | CCL |
| Date Received | 2011-08-09 |
| Lot Number | 814365 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-09 |