MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-16 for CARDIOCAP 5 manufactured by Ge Healthcare Finland Oy.
[77923717]
The date of device manufacture is not available. Ge healthcare's engineering team has confirmed the issue lies in a component (fet v8) failure of the device power supply due to wear out. There is no risk of fire related to this issue. The device was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[77923718]
It was reported the device emitted smoke when it was powered on by the user. The device was not connected to a patient when the issue occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2017-00041 |
| MDR Report Key | 6647391 |
| Date Received | 2017-06-16 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-06-16 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTOF SOOS |
| Manufacturer Street | 8200 W. TOWER AVE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARDIOCAP 5 |
| Generic Name | MONITOR, ST SEGMENT WITH ALARM |
| Product Code | MLD |
| Date Received | 2017-06-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |