MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-03-26 for ADVANTX manufactured by Ge Medical Systems Scs.
[4403916]
It was reported that images on the exam room live monitor were flickering. This issue may result in a degraded image quality that can prevent completion of an exam. No patient injury or death reported.
Patient Sequence No: 1, Text Type: D, B5
[11895703]
Initial reporter last name and email were not provided. This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury within the last three years. Reference mdr 9611343-2011-00001. 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: N, H10
| Report Number | 9611343-2014-00060 |
| MDR Report Key | 3829736 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2014-06-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS SCS |
| Manufacturer Street | 283 RUE DE LA MINIERE |
| Manufacturer City | BUC, YVELINES 78530 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 78530 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTX |
| Generic Name | GENERATOR, HIGH-VOLTAGE, X-RAY |
| Product Code | IZO |
| Date Received | 2014-03-26 |
| 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 | 283 RUE DE LA MINIERE BUC YVELINES 78530 FR 78530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-26 |