MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-03-09 for SOMNO TRAC (OMEGA) 4250 771990 manufactured by Sensormedics Corp..
[19492782]
While conducting an analysis of a sleeping pt, it was reported that the ampstar headbox was smoking and wires were burning. There were no injuries to anyone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1999-00036 |
| MDR Report Key | 213578 |
| Report Source | 05,06,07 |
| Date Received | 1999-03-09 |
| Date of Report | 1999-03-09 |
| Date of Event | 1999-02-16 |
| Date Mfgr Received | 1999-02-16 |
| Date Added to Maude | 1999-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMNO TRAC (OMEGA) |
| Generic Name | SLEEP DISORDER TESTING SYSTEM |
| Product Code | LEL |
| Date Received | 1999-03-09 |
| Returned To Mfg | 1999-03-08 |
| Model Number | 4250 |
| Catalog Number | 771990 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 207210 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 92887 US |
| Baseline Brand Name | SOMNOTRAC (OMEGA) |
| Baseline Generic Name | SLEEP DISORDER TESTING SYSTEM |
| Baseline Model No | 4250 |
| Baseline Catalog No | 771990 |
| Baseline ID | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915856 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-09 |