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

Model Number	10100
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rom technology's incident response protocols worked as designed (i.E., the safety/escalation process functioned properly).The issue was identified, corrected, and validated by qa the same day.A defect in the patient update api caused a critical cardiac safety field to be set to null, which allowed a patient to bypass the required pre-call.The incident was not caused by one isolated miss, but by a combination of: · defective update logic, · insufficient regression coverage around existing cardiac patient edits, · and missing system safeguards to prevent invalid production data.Corrective actions have been taken, and additional protections are being added at the database, api, testing, and monitoring levels.
Event or Problem Description
Patient was able to start rehab on her own without a cardiac rehab specialist call.Patient was able to pedal for 19 minutes unsupervised.Cardiac rehab specialist called and connected with patient, he stopped exercise as she reported 9/10 shortness of breath.She was allowed to sit and rest for a bit.Symptoms did not improve.Patient's physician was called at 4:18pm cst and was let know of the situation, he recommended that ems be sent to the patients home.The patient did not receive treatment for any life-threatening condition and any impairment was prevented based on patient's release from the hospital without admission.This was the result of a software bug that allowed the field "no_session_allowed_without_call" being set to null.The issue was fixed the same day as the incident with a software update, and additional protections are being added at the database, api, testing, and monitoring levels.

• 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: 24913522
• Report Number: 3015060244-2026-00005
• Device Sequence Number: 9828222
• Product Code: IKK
• UDI-Device Identifier: 00860002828718
• UDI-Public: (01)00860002828718(11)240322
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female