MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-03-01 for DEFINIUM 8000 manufactured by Ge Medical System, Llc.
[16915237]
"it was reported a third party service engineer sustained minor injuries while servicing a definium 8000 system. The service engineer felt a shock on his hand and fell backwards, sustaining minor bruises. There was no other injury reported an the event did not lead to a serious injury. The in house service personnel was replacing the column cable assembly on the overhead tube support. As part of the repair, the individual incorrectly connected the anode cable to the anode on the tube. The individual pulled the anode cable from the tube and discharged the stored capacitative energy to himself and fell from a ladder.
Patient Sequence No: 1, Text Type: D, B5
[16929562]
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 | 2126677-2013-00006 |
| MDR Report Key | 2992703 |
| Report Source | 01,06 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-01-30 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-01-30 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2013-03-21 |
| 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 | 0 |
| 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, LLC |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFINIUM 8000 |
| Generic Name | STATIONARY X-RAY SYSTEM |
| Product Code | IZF |
| Date Received | 2013-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEM, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-01 |