MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-12 for WATCHPAT100 manufactured by Itamar Medical Ltd..
[730735]
The medical device in question reports apnea hypopneas index that is used for the diagnosis of sleep apnea. The co misleads the physicians by claiming that the index has been fda approved when this is not the case -fda case k042916-. According to the index therapy or no therapy is decided. If therapy is missed and the pt is not treated while he should, complications may arise. A claim of such an index as fda approved while it is not, can have serious consequences on the well being of pts evaluated with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004413 |
| MDR Report Key | 948034 |
| Date Received | 2007-11-12 |
| Date of Report | 2007-11-12 |
| Date Added to Maude | 2007-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATCHPAT100 |
| Generic Name | WATCHPAT100 |
| Product Code | MNR |
| Date Received | 2007-11-12 |
| Model Number | WATCHPAT100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921095 |
| Manufacturer | ITAMAR MEDICAL LTD. |
| Manufacturer Address | 2 HAGESHEL ST CAESAREA IS 38900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-11-12 |