MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-14 for DELTA TRAK I 762850 manufactured by Sensormedics Corp..
[61859]
When the delta trak was first turned on, after a long period of non-use, it smelled as if something was hot or burning. The delta trak was turned off. There were no patients involved and there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1997-00064 |
| MDR Report Key | 91660 |
| Report Source | 05,06 |
| Date Received | 1997-05-14 |
| Date of Report | 1997-05-13 |
| Date of Event | 1997-04-21 |
| Date Mfgr Received | 1997-04-21 |
| Date Added to Maude | 1997-05-20 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA TRAK I |
| Generic Name | METABOLIC MEASUREMENT SYSTEM |
| Product Code | BZC |
| Date Received | 1997-05-14 |
| Returned To Mfg | 1997-04-29 |
| Model Number | NA |
| Catalog Number | 762850 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90547 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 928874645 US |
| Baseline Brand Name | DELTA TRAK I |
| Baseline Generic Name | METABOLIC MEASUREMENT SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 762850 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864603 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-14 |