MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-23 for SLEEP SOLUTION TESTER manufactured by Novasom, Inc.
[2836152]
Two years ago, the (b)(6) gave rptr a sleep apnea testing machine to test whether he had sleep apnea. The machine malfunctioned by giving him the wrong diagnosis of him having sleep apnea, when he did not. Pt was almost put on sleep apnea medication by the (b)(6). Pt believes that there are more (b)(6) pts that have been given the wrong diagnosis by the machine. The device is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026257 |
| MDR Report Key | 2666972 |
| Date Received | 2012-07-23 |
| Date of Report | 2012-07-23 |
| Date of Event | 2010-07-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | PATIENT |
| 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 |
| Generic Name | SLEEP SOLUTION TESTER |
| Product Code | MNR |
| Date Received | 2012-07-23 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVASOM, INC |
| Manufacturer Address | 801 CROMWELL PARK DR STE 108 GLEN BURNIE MD 21061 US 21061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-23 |