MAUDE Adverse Event Report: INNARA HEALTH/CARDINAL HEALTH NTRAINER SYSTEM 2.0; DEVICE, BIOFEEDBACK

Model Number	IN-5000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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: mw5157725.

• Brand Name: NTRAINER SYSTEM 2.0
• Common Device Name: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): INNARA HEALTH/CARDINAL HEALTH
• MDR Report Key: 19851184
• Report Number: MW5157724
• Device Sequence Number: 12859283
• Product Code: HCC
• UDI-Device Identifier: 00860009695207
• UDI-Public: (01)00860009695207(11)230519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: Health Professional
• Device Model Number: IN-5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown