MAC

Description of Event or Problem

DUE TO MULTIPLE 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 HOSPITAL FOUND DAMAGE TO THE TRUNK CABLES FOR 1 CABLE. 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. SERIAL NUMBERS ARE: (B)(6). MANUFACTURER RESPONSE FOR ELECTROCARDIOGRAPH, MAC (PER SITE REPORTER). GE'S RESPONSE IS TO APPLY A LABEL TO THE ACQUISITION MODULE. THIS IS NOT A SUFFICIENT SOLUTION. THE MODULES ARE STILL BEING STORED IN THE WRONG ORIENTATION BECAUSE IT IS POSSIBLE TO DO SO AND THE GE LOGO AND ALL WRITING ON THE MODULE IS IN ONE DIRECTION - LEAVING THE USER TO BELIEVE EASILY THAT IT SHOULD BE STORED WITH THE WRITING AND PICTURE FACING UPWARDS.