MAUDE Adverse Event Report: AMBU A/S AMBU AVIEW 2 ADVANCE

Model Number	405011000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for investigation, however, the device is not yet received by the manufacturer.Investigation will be performed as soon as the device is delivered at manufacturer.A follow-up report will be submitted when the investigation has been finalized.
Event or Problem Description
The user reported that the monitor was not responding and having issue booting up whilst trying to intubate a patient.Another monitor was used and the patient was intubated successfully.The user has reported that the monitor has worked again after a hard reset however they have noticed booting and shutting down issues with this monitor.
Additional Manufacturer Narrative
The device was returned to the manufacturer april 22nd, 2024.The investigation of the device has been initiated and is still on-going.A follow-up report/final report will be submitted when more investigations results are available or when the investigation has been finalized.
Event or Problem Description
The user reported that the monitor was not responding and having issue booting up whilst trying to intubate a patient.Another monitor was used and the patient was intubated successfully.The user has reported that the monitor has worked again after a hard reset however they have noticed booting and shutting down issues with this monitor.
Additional Manufacturer Narrative
Initial report (b)(6) 2024: the device is available for investigation; however, the device is not yet received by the manufacturer.Investigation will be performed as soon as the device is delivered at manufacturer.A follow-up report will be submitted when the investigation has been finalized.Follow-up report #1 (b)(6), 2024: the device was returned to the manufacturer (b)(6), 2024.The investigation of the device has been initiated and is still ongoing.A follow-up report/final report will be submitted when more investigations results are available or when the investigation has been finalized.Follow-up report #2 (b)(6) 2024: d4: udi related data quality updates.Only primary di number included, no pi number, as lot is unknown.G3: date updated to reflect when the new conclusion was provided by the investigation h6: c code updated and d added.H10: related report number added.As part of the investigating of the actual device, the unit was turned on and the software version was identified as v1.0.0.The log file was extracted and submitted to ambu software team for further analysis.From the log file evaluation it was possible to identify a normal start up behaviour of the system and the endoscope was plugged in and plugged out in two different connectors and in all the situations, the endoscope was correctly identified.After this a normal shutdown was executed.The analysis was done in the latest log entry available in the log file as there is no confirmation of the date of the incident.In the overall evaluation, it was not possible to identify the root cause, as no issue was associated in the log file related to the problem reported.
Event or Problem Description
The user reported that the monitor was not responding and having issue booting up whilst trying to intubate a patient.Another monitor was used and the patient was intubated successfully.The user has reported that the monitor has worked again after a hard reset however they have noticed booting and shutting down issues with this monitor.

• Brand Name: AMBU AVIEW 2 ADVANCE
• Common Device Name: AMBU AVIEW 2 ADVANCE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): BRITEMED TECHNOLOGY INC.; 3f, no.306, sec. 1, datong rd,; sijhih dist.; new taipei city, 22146 ; TW 22146
• Manufacturer Contact: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 19039919
• Report Number: 9610691-2024-00005
• Device Sequence Number: 18260716
• Product Code: FEM
• UDI-Device Identifier: 05707480145089
• UDI-Public: 05707480145089
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Model Number: 405011000
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 09/10/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/22/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown