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	02/09/2022
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- (b)(4) 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: 105-000345-00 rev.K, dfmea tower, platform 2.0, risk id: fmea-5030 to fmea-5060.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 804-47-1-1 (pdu e-stop error).The program development manager power cycled the system and reported that the cart was not producing the initialization clicks before the fault produced.The customer powered down the system and reviewed the pins inside the umbilical cable connector as discovered one pin was recessed in the umbilical cable connector.A physical examination of the cable assembly showed no damages.A visual examination of the cable connector did confirm multiple pins were recessed.The procedure was canceled that day and completed 2-days later successfully.

• 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: 14948417
• Report Number: 3014447948-2022-00012
• Device Sequence Number: 12299102
• Product Code: EOQ
• UDI-Device Identifier: B634MON00000501R0
• UDI-Public: +B634MON00000501R0/16D20210708
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MON-000005-01
• 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: 06/07/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown