FDA Adverse Event
Malfunction
Summary report: N
ADVANTX LCLP+
MDR report key: 1181712
·
Received September 30, 2008
Report
- Report Number
- 9611343-2008-00047
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 30, 2008
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K974367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WITH CARDIAC ARREST WAS ON THE TABLE BEFORE VASCULAR X-RAYS EXAMINATION BEGAN. THE PT RECEIVED DEFIBRILLATOR SHOCKS. WHEN THE X-RAY EXAMINATION STARTED, IMAGE QUALITY ALLEGEDLY BECAME VERY POOR. THE EXAM WAS INTERRUPTED AND THE PATIENT WAS MOVED TO ANOTHER SYSTEM TO RESUME AND COMPLETE THE EXAM. NO SERIOUS INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTX LCLP+ | VASCULAR X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS | 5172115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |