MalfunctionIKK
PORTABLECONNECT
Received Mar 26, 2026 · Event occurred Sep 5, 2025
Report 3015060244-2026-00003 · MDR key 24703899
Device
Generic name
System, Isokinetic Testing And Evaluation
Manufacturer
Rom TechnologiesModel number
10100Catalog number
10100
Product problems
- Material Integrity Problem
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.
Remedial action
- Other