BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU AVIEW 2 ADVANCE

    MDR report key: 19048038 · Received April 4, 2024

    Report

    Report Number
    1220828-2024-00006
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Report Date
    October 2, 2024
    Manufacturer
    AMBU A/S
    Product Code
    FEM
    UDI-DI
    05707480145089
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1220828-2024-00006 REPORTED APRIL 4, 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 #1 MDR 1220828-2024-00006 REPORTED MAY 22, 2024: THE DEVICE WAS RETURNED TO THE MANUFACTURER APRIL 22ND, 2024. THE INVESTIGATION OF THE DEVICE HAS BEEN INITIATED AND IS STILL ONGOING. A FOLLOW-UP REPORT/FINAL REPORT WILL BE SUBMITTED WHEN MORE INVESTIGATIVE RESULTS ARE AVAILABLE OR WHEN THE INVESTIGATION HAS BEEN FINALIZED. FOLLOW-UP REPORT #2 OCTOBER 02, 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 WAS THE NEW CONCLUSION 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.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1220828-2024-00006 REPORTED APRIL 4, 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 #1 MDR 1220828-2024-00006 REPORTED MAY 22, 2024: THE DEVICE WAS RETURNED TO THE MANUFACTURER APRIL 22ND, 2024. THE INVESTIGATION OF THE DEVICE HAS BEEN INITIATED AND IS STILL ONGOING. A FOLLOW-UP REPORT/FINAL REPORT WILL BE SUBMITTED WHEN MORE INVESTIGATIVE RESULTS ARE AVAILABLE OR WHEN THE INVESTIGATION HAS BEEN FINALIZED.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018088 AMBU AVIEW 2 ADVANCE AMBU AVIEW 2 ADVANCE FEM AMBU A/S 05707480145089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown