MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-03-03 for LC VASCULAR + manufactured by Ge Medical Systems.
[1869356]
It was reported that there was intermittent image flickering and image shrinking during acquisition of fluoroscopic exposure. Tests were conducted and no problem was encountered. The system was restored to normal operation. The issue may result in a degraded image quality that can prevent completion of an exam. No patient injury or death reported. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9174510]
This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury within the last two years. Reference mdr 9611343-2011-00001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611343-2011-00009 |
| MDR Report Key | 2054033 |
| Report Source | 01,06 |
| Date Received | 2011-03-03 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-01-16 |
| Date Mfgr Received | 2011-02-03 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2011-07-06 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS |
| Manufacturer City | BUC |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LC VASCULAR + |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM |
| Product Code | IZO |
| Date Received | 2011-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | BUC FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-03 |