MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-26 for CARDIOCAP 5 manufactured by Ge Healthcare.
[2598994]
It was reported that the hospital staff smelled and saw smoke from the cardiocap 5 patient monitor during patient use. There was no report of fire or flames. The cause of the smoke has not been identified. The monitor was immediately removed from use. There was no serious injury or death associated with this event. Nor was medical intervention required. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2012-00014 |
| MDR Report Key | 2508516 |
| Report Source | 05,06 |
| Date Received | 2012-03-26 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-01 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2012-09-05 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCAP 5 |
| Generic Name | PATIENT MONITOR |
| Product Code | MLD |
| Date Received | 2012-03-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-26 |