MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-04 for PRECISION PM1000 manufactured by Precison Medical.
[4819228]
Patient on o2 via oxygen flow meter. The oxygen flow selector was turned to the wrong port, off instead of on. Rt assisting patient found patient desat at 85%. Rt adjusted oxygen flow selector to the correct port and o2 stat went up to 97%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037655 |
| MDR Report Key | 3986980 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-07-02 |
| Date Added to Maude | 2014-08-11 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PRECISION |
| Generic Name | FLOW SELECTOR |
| Product Code | CAX |
| Date Received | 2014-08-04 |
| Model Number | PM1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISON MEDICAL |
| Manufacturer Address | NORTHHAMPTON 18067 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-04 |