MAC
Received May 15, 2025 · Event occurred Apr 30, 2025
Report 22024752 · MDR key 22024752
Device
Product problems
- Activation, Positioning or Separation Problem
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DUE TO 5 RECENTLY REPORTED INCIDENTS OF GE MAC VU 360 ACQUISITION MODULE TRUNK CABLES BEING REPORTED TO HAVE SPARKS/FLAMES/FIRE, THE OFFICE INSTRUCTED ALL HOSPITALS TO INSPECT THEIR ACQUISITION MODULE TRUNK CABLES FOR DAMAGE. ONE WAS FOUND WITH SIGNIFICANT DAMAGE TO THE TRUNK CABLE AND IN THE WRONG ORIENTATION IN THE MODULE HOLDER AT ONE SINGULAR FACILITY. MORE WERE FOUND AT OTHER FACILITIES AND WILL BE DETAILED IN ADDITIONAL MEDSUN REPORTS. WHILE THIS DAMAGED CABLE DOES NOT SHOW EVIDENCE OF BURNING, THE SAME FAILURE MODE IS LIKELY TO HAVE CAUSED THE DAMAGE TO THESE TWO TRUNK CABLES - PUTTING THE ACQUISITION MODULE IN THE HOLDER IN THE WRONG ORIENTATION. THIS IS A DESIGN PROBLEM THAT NEEDS TO BE ADDRESSED BY GE TO PREVENT THE ACQUISITION MODULE FROM GOING IN THE HOLDER IN THE INCORRECT POSITION. MANUFACTURER RESPONSE FOR ELECTROCARDIOGRAPH, MAC (PER SITE REPORTER). THEY ARE LOOKING INTO THIS ISSUE.