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 1996-12-06 for PULMONARY/METABOLIC SYSTEM (VMAX SERIES) VMAX 299 769200 manufactured by Sensormedics Corp..
[38871]
While testing a pt on the vmax299, smoke was observed coming out of the back right corner of the analyzer module. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-00042 |
| MDR Report Key | 56516 |
| Report Source | 05,06,07 |
| Date Received | 1996-12-06 |
| Date of Report | 1996-12-06 |
| Date of Event | 1996-11-14 |
| Date Mfgr Received | 1996-11-14 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 1996-12-19 |
| 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 | PULMONARY/METABOLIC SYSTEM (VMAX SERIES) |
| Generic Name | PULMONARY/METABOLIC TESTER |
| Product Code | BZC |
| Date Received | 1996-12-06 |
| Returned To Mfg | 1996-11-22 |
| Model Number | VMAX 299 |
| Catalog Number | 769200 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 57036 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PARKWAY YORBA LINDA CA 928874645 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-06 |