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 ADVANTX LC+ manufactured by Ge Medical Systems Scs.
[1877104]
It was reported that an advantx system was experiencing a flickering of the image on the live monitor. 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 into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9110294]
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 | 9611343-2011-00010 |
| MDR Report Key | 2054029 |
| Report Source | 01,06 |
| Date Received | 2011-03-03 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-01-17 |
| Date Mfgr Received | 2011-02-03 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2011-05-12 |
| 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 SCS |
| Manufacturer City | BUC |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTX LC+ |
| Generic Name | VASCULAR 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 SCS |
| Manufacturer Address | BUC FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-03 |