MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. INQUIRY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81531
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Artifact at distal end of catheter.No harm to patient.Procedure completed, unknown if new catheter was used.

• Brand Name: INQUIRY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC.; 2375 morse avenue; irvine CA 92614
• MDR Report Key: 11900574
• Report Number: 11900574
• Device Sequence Number: 3692804
• Product Code: DRF
• UDI-Device Identifier: 05414734304788
• UDI-Public: (01)05414734304788(17)240131(10)7827786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/20/2021
• Report Date (Section F): 05/20/2021

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: IBI-81531
• Device Catalogue Number: IBI-81531
• Device Lot Number: 7827786
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 05/20/2021