MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-17 for CARDIOCAP 5 manufactured by Ge Healthcare Finland Oy.
[5495002]
The customer reported a burning smell and black smoke emitting from the device. No patient compromise.
Patient Sequence No: 1, Text Type: D, B5
[12830287]
Manufacture date unknown at this time. 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: N, H10
[28710223]
Investigation revealed the received faulty smoking part was a cc5 power supply manufactured in 2001. The components near fet v8 were found to be burned. The root cause is a wear out phenomena. The cc5 monitor power supply was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2015-00004 |
| MDR Report Key | 4520706 |
| Report Source | 05,06 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-01-21 |
| Date of Event | 2015-01-21 |
| Date Mfgr Received | 2015-03-26 |
| Date Added to Maude | 2015-03-20 |
| 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 | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | KUORTANEENKATU 2 |
| Manufacturer City | HELSINKI, 510 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCAP 5 |
| Generic Name | MONITOR, ST SEGMENT WITH ALARM |
| Product Code | MLD |
| Date Received | 2015-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI, 510 FI 510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-17 |