MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-05-22 for ADVANTX LC manufactured by Ge Medical Systems Scs.
[20020460]
It was reported that thrust bearings on the monitor bridge are not in correct alignment. The bearings were reported to be pushed up in front of the lip of the stationary rail. Aluminum flakes were reportedly dropping into the pt sterile field. No pt injury was reported. The field svc engineer cleaned the flaking aluminum off of the rails and readjusted the thrust bearings. 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
| Report Number | 9611343-2008-00030 |
| MDR Report Key | 1051800 |
| Report Source | 05,07 |
| Date Received | 2008-05-22 |
| Date of Report | 2008-05-22 |
| Date of Event | 2008-04-23 |
| Date Mfgr Received | 2008-04-23 |
| Date Added to Maude | 2010-02-02 |
| 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 | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DR MAIL STO: RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | GE MEDICAL SYSTEMS SCS |
| Manufacturer City | BUC CEDEX |
| Manufacturer Country | FR |
| Single Use | 0 |
| 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 | 2008-05-22 |
| 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 CEDEX FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-22 |