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 2008-01-03 for CARDIOCAP 5 M0023191 manufactured by Ge Healthcare Finland Oy.
[19056112]
Customer reported that a child was receiving proton beam accelerator treatment. Patient was reportedly under anesthesia. During treatment, hospital staff reportedly noted cardiocap 5 started to smoke and flames were subsequently noted. Unit was unplugged and removed from the room. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2008-00001 |
| MDR Report Key | 973262 |
| Report Source | 05,06,07 |
| Date Received | 2008-01-03 |
| Date of Report | 2008-01-03 |
| Date of Event | 2007-12-05 |
| Date Mfgr Received | 2007-12-05 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2008-09-02 |
| 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 | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DR. MAIL CODE-RP2138 |
| Manufacturer City | WALWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| 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 | PHYSIOLOGIC PATIENT MONITOR |
| Product Code | MLD |
| Date Received | 2008-01-03 |
| Model Number | M0023191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 977390 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-03 |