MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for OXYGEN FLOWMETER 0197 manufactured by Precision Medical, Inc..
[89845846]
Patient Sequence No: 1, Text Type: N, H10
[89845847]
Patient was on 4l/nc o2 and his sats were 61%. O2 was on. The regulatory was changed out and the patient's sats went up to 91%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6965120 |
| MDR Report Key | 6965120 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-09-26 |
| Date of Event | 2016-12-05 |
| Report Date | 2017-09-26 |
| Date Reported to FDA | 2017-09-26 |
| Date Reported to Mfgr | 2017-09-26 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | OXYGEN FLOWMETER |
| Generic Name | FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED |
| Product Code | CAX |
| Date Received | 2017-10-20 |
| Model Number | 0197 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |