MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-06 for CARDIOCAP 5 manufactured by Ge Healthcare.
[2116693]
It was reported that there was a burning smell and the monitor stopped working. Replacement of the power supply and battery on the cardiocap 5 pt monitor was required. There was no death or serious injury associated with this event. Ge healthcare's investigation is ongoing. A f/u report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9283134]
The exact incident date is unk, but it is believed that the event occurred on or before (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2011-00011 |
| MDR Report Key | 2147045 |
| Report Source | 06 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-06-07 |
| Date of Event | 2011-05-09 |
| Date Mfgr Received | 2011-05-09 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2011-09-27 |
| 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 |
| 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 | PHYSIOLOGICAL PATIENT MONITOR |
| Product Code | MLD |
| Date Received | 2011-06-06 |
| Operator | OTHER |
| 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 | 2011-06-06 |