MAUDE Adverse Event Report: ROM TECHNOLOGIES PORTABLECONNECT; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number	10100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The power cord got tangled in the pedals and was broken, exposing conductors.
Additional Manufacturer Narrative
We were performing a retrospective review of complaints as a result of a previous mdr to identify any devices exhibiting a similar issue.

• Brand Name: PORTABLECONNECT
• Common Device Name: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): ROM TECHNOLOGIES; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): ROM TECHNOLOGIES; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: john belles ; 101 silvermine road; brookfield, CT 06804 ; 2038927294
• MDR Report Key: 24703899
• Report Number: 3015060244-2026-00003
• Device Sequence Number: 13377848
• Product Code: IKK
• UDI-Device Identifier: 00860002828718
• UDI-Public: (01)00860002828718(11)220526
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10100
• Device Catalogue Number: 10100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female