MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-23 for INNOVA 2000 * manufactured by Ge Medical Systems, Llc.
[2173400]
Patient was having a heart attack during the critical part of his heart catheterization. The stent was being deployed. The x-ray system suddenly stopped working. Attempts to reboot failed. The patient had to be moved to a different room resulting in a 20 minute delay in his immediate care. System error logs were reviewed and are being submitted to the manufacturer for future analysis. Cause unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2240748 |
| MDR Report Key | 2240748 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-08-18 |
| Report Date | 2011-08-23 |
| Date Reported to FDA | 2011-08-23 |
| Date Added to Maude | 2011-09-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVA 2000 |
| Generic Name | X-RAY SYSTEM, CATH/ANGIO |
| Product Code | IZO |
| Date Received | 2011-08-23 |
| Model Number | INNOVA 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-23 |