MAUDE Adverse Event Report: MYOLYN INC. MYOCYCLE MC-2; FES CYCLE ERGOMETER

Model Number MC-2

Device Problem Mechanical Problem (1384)

Patient Problem Electric Shock (2554)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

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).

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.

• Brand Name: MYOCYCLE MC-2
• Type of Device: FES CYCLE ERGOMETER
• Manufacturer (Section D): MYOLYN INC.; 6931 nw 22nd st; gainesville 32653
• Manufacturer (Section G): MYOLYN INC.; 6931 nw 22nd st; ste a; gainesville 32653
• Manufacturer Contact: woodrow starnes ; 6931 nw 22nd st; ste a; gainesville 32653 ; 3522925037
• MDR Report Key: 15209093
• MDR Text Key: 305164769
• Report Number: 3013503259-2022-00001
• Device Sequence Number: 1
• Product Code: GZI
• UDI-Device Identifier: 00861553000417
• UDI-Public: (01)00861553000417(11)220601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MC-2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3013503259-7/18/22-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White