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 1998-11-23 for METABOLIC MEASUREMENT CART 2900 21353 manufactured by Sensormedics Corp..
[117482]
The user of the model 2900 reported something burned inside, "toxic" fumes, electrical smell. There was no pt involvement and there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1998-00087 |
| MDR Report Key | 198611 |
| Report Source | 05,06,07 |
| Date Received | 1998-11-23 |
| Date of Report | 1998-11-23 |
| Date of Event | 1998-11-09 |
| Date Mfgr Received | 1998-11-09 |
| Device Manufacturer Date | 1986-09-01 |
| Date Added to Maude | 1998-11-25 |
| 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 | METABOLIC MEASUREMENT CART |
| Generic Name | METABOLIC MEASUREMENT SYSTEM |
| Product Code | BZC |
| Date Received | 1998-11-23 |
| Returned To Mfg | 1998-11-19 |
| Model Number | 2900 |
| Catalog Number | 21353 |
| 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 | 192940 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 92887 US |
| Baseline Brand Name | METABOLIC MEASUREMENT CART |
| Baseline Generic Name | METABOLIC MEASUREMENT SYSTEM |
| Baseline Model No | 2900 |
| Baseline Catalog No | 21353 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915686 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-23 |