MYOCYCLE MC-2

Description of Event or Problem

ON (B)(6) 2022, MYOLYN RECEIVED A CUSTOMER COMPLAINT ABOUT MYOCYCLE MC-2 (B)(4) FAILING TO POWER ON. MYOLYN INITIATED A VIDEO CALL WITH THE CUSTOMER TO INVESTIGATE THE CAUSE. DURING THE CALL, THE CUSTOMER HEARD LOOSE SCREWS INSIDE THE DEVICE POWER ELECTRONICS BOX. THE CUSTOMER REMOVED THIS BOX AND RETURNED IT TO MYOLYN FOR FURTHER INVESTIGATION, WHERE IT WAS FOUND THAT THE LOOSE SCREWS WERE THOSE INTENDED FOR MOUNTING THE DEVICE POWER SUPPLY IN PLACE INSIDE THE POWER ELECTRONICS BOX. INVESTIGATION ALSO REVEALED THAT ONE SCREW HAD CAUSED AN ELECTRICAL SHORT CIRCUIT ON THE POWER SUPPLY INPUT, RESULTING IN FAILURE OF THE POWER SUPPLY. MYOLYN CONCLUDED THAT THE POWER SUPPLY MOUNTING SCREWS HAD COME LOOSE DURING SHIPPING AS A RESULT OF VIBRATION AND MECHANICAL SHOCK. LOOSE POWER SUPPLY MOUNTING SCREWS CAN RESULT IN A LOSS OF PROTECTION AGAINST HIGH VOLTAGE ELECTRICAL SHOCK, INCREASING THE RISK FOR SERIOUS INJURY AND/OR DEATH, WITH THE RISK BEING PROPORTIONATE TO THE NUMBER OF LOOSE SCREWS (OUT OF FOUR) AND DEGREE OF LOOSENING (I.E., PARTIALLY LOOSE SCREWS REPRESENT A MUCH LOWER RISK THAN COMPLETELY LOOSE SCREWS).

Additional Manufacturer Narrative

THERE WERE MULTIPLE PROBLEMS WITH THE APPLICATION FREEZING AND THEN NOT TAKING THE CODE WHEN ATTEMPTING TO ENTER THE ADVERSE EVENT PROBLEM CODE. THE CODE, WHICH WAS RECEIVED OFF OF THE IMDRF DOCUMENT REPOSITORY IS A0501.