FDA Adverse Event
Malfunction
Summary report: N
ADVANTX LC, LC+, LCA, LCV+ CABLES
MDR report key: 312226
·
Received January 5, 2001
Report
- Report Number
- 6000088-2000-00025
- Event Type
- Malfunction
- Date Received
- January 5, 2001
- Date of Event
- October 20, 2000
- Report Date
- November 27, 2000
- Manufacturer
- GE MEDICAL SYSTEMS EUROPE
- Product Code
- IZI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO GEMS THAT DURING A MANUFACTURING REVIEW OF THE VENDOR-PRODUCED CABLES 218693, 2224900, 2141260 AND 2142229, USED IN ALL ADVANTX VASCULAR SYSTEMS (I.E., FOR IDF OPTION), A PRODUCTION ERROR INVOLVING INSULATION ALLOWS THE SCREW FROM THE CONNECTOR ATTACHMENT CLAMP TO COME INTO CONTACT WITH ONE OF THE PHASE LEADS OF THE CABLE RESULTING IN AN ELECTRICAL SHOCK HAZARD. CORRECTIVE ACTIONS AT BOTH THE VENDOR AND AT GE HAVE BEEN IMPLEMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756 | ADVANTX LC, LC+, LCA, LCV+ CABLES | DIAGNOSTIC X-RAY | IZI | GE MEDICAL SYSTEMS EUROPE | 2186963, 2142229, 2224900, & 2141260 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |