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

Model Number IBI-81104

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Event Description

Prior to use on patient, it was discovered the user was unable to steer the device "c" shape.It was "s" shape.Device was not used on patient.

• Brand Name: INQUIRY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 9309413
• MDR Text Key: 165977207
• Report Number: 9309413
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2019

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
• Device Operator: No Information
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 7077974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2019
• Date Report to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA