MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-03 for MAQUET manufactured by Maquet.
[2065260]
Pt was switched from one mode of ventilation to another and while at the bedside, the oxygen analyzer started to fluctuate from 58-70%. Pt was agitated and saturations dropped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021645 |
| MDR Report Key | 2196884 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-08-03 |
| Date of Event | 2011-08-01 |
| Date Added to Maude | 2011-08-15 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET |
| Generic Name | OXYGEN ANALYZER SERVO I |
| Product Code | CCL |
| Date Received | 2011-08-03 |
| ID Number | 01 016 455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-03 |