MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for GE CARDIO INNOVA 3100 HARMONY manufactured by Ge Healthcare.
[177356548]
During intervention of right coronary bypass graft/stent placement, ge innova t-ray equipment had a "cooling failure / secure patient / shutting off in 3 min" warning, machine shut down, 1 gallon of coolant added to chiller, rebooted machine with no warnings noted. Continued with procedure. Pt remained stable through out the 10 min reboot with no untoward effects noted. X-ray machine shut down at a critical time. A stent had been deployed and the cardiologist was unable to visualize the artery for any possible complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092625 |
| MDR Report Key | 9646805 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-16 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE |
| Generic Name | FLUOROSCOPIC INTERVENTIONAL X-RAY SYSTEM |
| Product Code | JAA |
| Date Received | 2020-01-29 |
| Model Number | CARDIO INNOVA 3100 HARMONY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-29 |