MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for SURGICAL C-ARM 9900 ELITE manufactured by Ge (oem) Healthcare Surgery.
[139307264]
A large c-arm was being used for a procedure. As normal, the x-ray tech announced the amount of time the c-arm was in use at the 5 min, 10 min, 15 min and 20 min. After 20 min, the c-arm showed a warning message that it was overheating. The c-arm then stopped working. The tube heat monitoring components did not operate normally, system did not announce and event messages at 80% of heat threshold reached (as if should per mfr settings). System disabled x-ray when it reached 127% of heat threshold. After clinical engineering tested system and reached out to vendor tech support, a software reload and replacement of thermal switch / temp sensor were suggested and carried out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8433796 |
| MDR Report Key | 8433796 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-03-07 |
| Date Facility Aware | 2019-03-07 |
| Report Date | 2019-03-13 |
| Date Reported to FDA | 2019-03-13 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SURGICAL C-ARM |
| Generic Name | SURGICAL C-ARM |
| Product Code | JAA |
| Date Received | 2019-03-15 |
| Model Number | 9900 ELITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE (OEM) HEALTHCARE SURGERY |
| Manufacturer Address | 384 WRIGHT BROTHERS DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-15 |