MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for RESMED AIRSENSE 10 manufactured by Resmed.
[94196531]
Auto adjust cpap misreported device function and patient use. Patient was on auto adjust cpap device, device reported no pressure, flow, breathing rate, tidal volume or respirations. Not able to determine if medical device was working and/or if data was missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073761 |
| MDR Report Key | 7086790 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-25 |
| Date Added to Maude | 2017-12-06 |
| 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 | RESMED AIRSENSE 10 |
| Generic Name | RESMED AIRSENSE 10 |
| Product Code | MNR |
| Date Received | 2017-12-04 |
| Model Number | AIRSENSE 10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED |
| Manufacturer Address | AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-04 |