E-NMT MODULE

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: WHILE DEMONSTRATING THE NMT SYSTEM AT A CUSTOMER SITE, THE GE HEALTHCARE (GEHC) EMPLOYEE, TO WHOSE HAND THE ELECTRODES WERE ATTACHED, WAS SHOCKED WHEN THE CUSTOMER PRESSED THE "TETANIC STIMULATION" BUTTON ON THE DEVICE. THE EMPLOYEE WAS TREATED FOR PAIN AND NUMBNESS TO THEIR HAND. GEHC'S INVESTIGATION CONCLUDED THE ROOT CAUSE WAS USE ERROR, AS THE CUSTOMER WAS NOT SUPPOSED TO INTERACT WITH THE DEVICE WHILE THE GEHC EMPLOYEE WAS DEMONSTRATING IT. GEHC DID NOT IDENTIFY ANY PRODUCT DEFECT, OR ANY PROCESS/DESIGN ISSUES RELATED TO THIS EVENT. H3 OTHER TEXT : DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510. A1-6: THERE WAS NO PATIENT CONNECTED TO THE DEVICE AT THE TIME. D4: THE SERIAL NUMBER AND UDI WERE NOT PROVIDED. H14: NOT AVAILABLE BECAUSE THE SERIAL NUMBER IS UNKNOWN. GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. H3 OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem

WHILE DEMONSTRATING THE NMT SYSTEM, A GE HEALTHCARE EMPLOYEE, TO WHOM THE ELECTRODES WERE ATTACHED, RECEIVED A SHOCK TO HER HAND/ARM WHEN THE CUSTOMER INADVERTENTLY PRESSED A BUTTON ON THE DEVICE WHICH CAUSED THE SHOCK.