MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for ARES WATERMARK MODEL 610 OXIMETER manufactured by Watermark Medical.
[102951585]
Pt with oximeter burn to forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075966 |
| MDR Report Key | 7352198 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-02-22 |
| Date Added to Maude | 2018-03-20 |
| 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 | 3 |
| Brand Name | ARES WATERMARK MODEL 610 OXIMETER |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2018-03-19 |
| Model Number | 610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL |
| Manufacturer Address | WEST PALM BEACH FL 33409 US 33409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-19 |