MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for WATCH PAT 200 manufactured by Itamar Medical Inc..
[110183523]
I used the watch pat 200 for my sleep apnea and i don't think the device is functioning right. I don't think they are calibrating the device right in their office for repair. Date of use: 8 hours. Diagnosis or reason for use: sleep issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077631 |
| MDR Report Key | 7568825 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-21 |
| Date Added to Maude | 2018-06-05 |
| 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 | 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 | 0 |
| Brand Name | WATCH PAT 200 |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2018-06-04 |
| Model Number | WATCH PAT 200 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITAMAR MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-04 |