MalfunctionIKK
PORTABLECONNECT
Received Mar 26, 2026 · Event occurred Oct 15, 2024
Report 3015060244-2026-00004 · MDR key 24705009
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
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.
Description of Event or Problem
POWER CORD WRAPPED AROUND THE PEDALS AND IS NOW FRAYED, EXPOSING THE CONDUCTORS.
Remedial action
- Other