MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for O2 FLOW METER 0197 manufactured by Precision Medical, Inc..
[145031497]
While bagging a pt, the rt came in and stated that earlier she had trouble with the flow meter that the bag was on during an epi. I quickly changed it to the other 15 liter flow meter in the room and resumed bagging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086581 |
| MDR Report Key | 8604954 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-29 |
| Date Added to Maude | 2019-05-13 |
| 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 |
| 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 | 0 |
| Brand Name | O2 FLOW METER |
| Generic Name | FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED |
| Product Code | CAX |
| Date Received | 2019-05-10 |
| Model Number | 0197 |
| Lot Number | 300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |