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

Model Number	10100
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power cord wrapped around the pedal and broke, exposing conductors.

• Brand Name: PORTABLECONNECT
• Common Device Name: ISOKINETIC TESTING AND EVALUATION SYSTEM
• Manufacturer (Section D): ROM TECHNOLOGIES, INC; 101 silvermine rd.; brookfield 06804
• Manufacturer (Section G): ROM TECHNOLOGIES, INC; 101 silvermine rd.; brookfield 06804
• Manufacturer Contact: patrick freeman ; 101 silvermine rd.; brookfield, CT 06804 ; 2037100980
• MDR Report Key: 24168025
• Report Number: 3015060244-2026-00001
• Device Sequence Number: 18397056
• Product Code: IKK
• UDI-Device Identifier: 00860002828718
• UDI-Public: (01)00860002828718(11)210501
• Combination Product (Y/N): N
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2021
• 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