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

Model Number	MON-000005-01
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of similar complaint notes this to be a known issue and the cause is associated with the female connector on the cart e-panel.Capa-010450 was initiated to correct the issue.A review of the device history record (dhr) is not required as the subject part is a supplied item.A review of nonconforming report show no report that would relate to the reported issue.The risk associated with the reported issue is noted in: risk document number: ((b)(4)., platform 2.0, risk id: (b)(4).No action is required based on risk acceptance.The incident will continue to be tracked in regular trend review meetings.
Event or Problem Description
It was reported that the patient underwent a monarch bronchoscopy procedure.During that procedure the monarch system reported having fault 804-46-0-0 (pdu e-stop error).The bronchoscope was removed, and the monarch was power cycled.After the system powered on, the same fault returned.Program development manager (pdm) checked the e-stop button on the cart, and it was not illuminated, so the pdm was instructed to power cycle from the tower software.Once the system was completely off, pdm checked the umbilical cable and discovered a recessed pin inside the umbilical cable.The procedure was aborted and rescheduled for a later date.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065
• MDR Report Key: 14948071
• Report Number: 3014447948-2022-00013
• Device Sequence Number: 6196214
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20211122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193534
• 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: Nurse
• Type of Report: Initial

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: MON-000005-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown