BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCYCLE MC-2

    MDR report key: 15209093 · Received August 11, 2022

    Report

    Report Number
    3013503259-2022-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    June 29, 2022
    Report Date
    August 9, 2022
    Manufacturer
    MYOLYN INC.
    Product Code
    GZI
    UDI-DI
    00861553000417
    PMA / PMN Number
    K213925
    Removal / Correction Number
    3013503259-7/18/22-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720170 MYOCYCLE MC-2 FES CYCLE ERGOMETER GZI MYOLYN INC. MC-2 N/A 00861553000417

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Life Threatening