MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for COROMETRICS 250CX SERIES MODEL 259CX manufactured by Wipro Ge Healthcare Private Limited.
[123555991]
Iupc - internal uterine pressure monitor in use, cable connection on the machine started smoking, making noise and staff smelled burning. This happened at the machine and did not reach the patient. Patient removed from the room and machine was taken to bio med. Manufacturer response for intra uterine pressure catheter, coro metrics - 250cx (per site reporter). This is a brand new piece of equipment; manufacturer requested the device be returned to them. No status information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7960548 |
| MDR Report Key | 7960548 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-06 |
| Report Date | 2018-09-27 |
| Date Reported to FDA | 2018-09-27 |
| Date Reported to Mfgr | 2018-10-12 |
| Date Added to Maude | 2018-10-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | COROMETRICS 250CX SERIES |
| Generic Name | SYSTEM, MONITORING, PERINATAL |
| Product Code | HGM |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-09-11 |
| Model Number | MODEL 259CX |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WIPRO GE HEALTHCARE PRIVATE LIMITED |
| Manufacturer Address | 3000 N GRANDVIEW BLVD W-450 WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |