MalfunctionHCC

NTRAINER SYSTEM 2.0

Received Jul 26, 2024 · Event occurred Jul 25, 2024

Report MW5157725 · MDR key 19851236

Device

Generic name

Device, Biofeedback

Manufacturer

Innara Health/cardinal Health

Model number

IN-5000

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

OUR HOSPITAL HAS TWO CARDINAL HEALTH INNARA HEALTH NTRAINER SYSTEM 2.0 SERIAL (B)(6). WE CONTACTED CARDINAL HEALTH FOR SERVICE ON THE NTRAINER PROVIDED THEM WITH SERIAL NUMBERS AND THEY HAD NO RECORDS ON THEIR SYSTEM OF EXISTING. THIS IS AN ISSUE IF THERE ARE ANY SAFETY RECALLS OR ISSUES WITH EQUIPMENT AND WE ARE NOT NOTIFIED. REFERENCE REPORT: MW5157724.