MalfunctionLMD
GE MACH LAB
Received Sep 28, 2004 · Event occurred Sep 24, 2004
Report 546735 · MDR key 546735
Device
Generic name
Ge Mach Lab - Optical Drive
Manufacturer
Ge Medical SystemModel number
PN 2016283-002Catalog number
*
Lot number
*
Product problems
- EKG/ECG analysis, failure to perform
- Monitor failure
- Unable to Obtain Readings
Patient
60 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING STENT DEPLOYMENT OPTICAL DRIVE OF GE MACH LAB - NO EKG, NO PRESSURE TRACING, NOR OXIMETRY.