MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-10 for GE OEC 9800 NA manufactured by Ge Oec Medical Systems Inc..
[20200871]
The ge oec 9800 fluoroscopy system had a "pre-charge failure error" message displayed and the system was then inoperable.
Patient Sequence No: 1, Text Type: D, B5
[20452825]
A ge oec service representative investigated the issue and found a connector inside the remote user interface that needed to be repaired. The service representative repaired the connection, tested the rui and found it to be working as intended. There was no reported patient involvement due to this system malfunction. The system was released to the customer for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720753-2007-00634 |
| MDR Report Key | 962219 |
| Report Source | 05,06 |
| Date Received | 2007-05-10 |
| Date of Report | 2007-05-09 |
| Date of Event | 2007-04-10 |
| Date Mfgr Received | 2007-04-10 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2007-12-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARIA FRAME, VP |
| Manufacturer Street | 384 WRIGHT BROTHERS DR. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015176440 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE OEC 9800 |
| Generic Name | FLUOROSCOPIC X-RAY |
| Product Code | JJA |
| Date Received | 2007-05-10 |
| Model Number | GE OEC 9800 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 932219 |
| Manufacturer | GE OEC MEDICAL SYSTEMS INC. |
| Manufacturer Address | * SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-10 |