MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number	MBR-000211-A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the patient was on the table under anesthesia physician experienced em sensor error.The physician elected to abort the case.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline dr.; redwood city, CA 94065 ; 6282544750
• MDR Report Key: 21032403
• Report Number: 3014447948-2024-00029
• Device Sequence Number: 19835489
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D202503087
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K231473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Expiration Date: 03/08/2025
• Device Model Number: MBR-000211-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown