MalfunctionDRR
GE CARDIOLAB
Received Jan 8, 2008 · Event occurred Dec 19, 2007
Report MW5004932 · MDR key 978288
Device
Product problems
- No Display/Image
- Repair
- Device Displays Incorrect Message
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING AN SVT ABLATION IN THE ELECTROPHYSIOLOGY LAB, THE GE CARDIOLAB SYSTEM DISPLAYED "ERROR" MESSAGE ON THE SCREEN. IT THEN STOPPED REAL-TIME MONITORING THE PATIENT. THIS PATIENT WAS CONTINUALLY MONITORED BY USING THE ZOLL DEFIBRILLATOR AS A CARDIAC MONITOR. THE GE SYSTEM REBOOTED AFTER THREE MINS. THE PATIENT EXPERIENCED NO ADVERSE AFFECTS.