BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 17731562 · Received September 12, 2023

    Report

    Report Number
    3010532612-2023-00526
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 28, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF "POWER SUPPLY FAILURE" WAS CONFIRMED UPON THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A CONDOR POWER SUPPLY (PART NUMBER: 77-0063-001, S/N: (B)(6)) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING (INP-1, INP-2). VISUAL INSPECTION OF THE POWER SUPPLY WAS PERFORMED (INP-5 THROUGH INP-12) AND NO ABNORMALITY WAS NOTED. THE POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AC2 FOR FUNCTIONAL TESTING. THE PUMP WAS UNABLE TO POWER-UP. THE POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AC2 SERIES SERVICE MANUAL AND ALL OUTPUT VOLTAGES WERE NOT PRESENT ALONG WITH BLANK SCREEN ON POWER-UP. AN EXAMINATION OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED BECAUSE THE DHR INFORMATION WAS UNAVAILABLE, BUT THE SERVICE HISTORY INFORMATION WAS REVIEWED FOR THE REPORTED COMPLAINT. THERE WERE NO PROBLEMS IDENTIFIED DURING THE REVIEW OF THE SERVICE HISTORY FOR THIS DEVICE. HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO NO OUTPUT VOLTAGES. THE ROOT CAUSE OF THE POWER SUPPLY VOLTAGE OUTPUT FAILURE WAS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ERROR DETECTED BY HOSPITAL SERVICE ENGINEERS DURING EQUIPMENT ORDINARY CHECK. THE PUMP DISPLAYS 'SYSTEM RUNNING ON BATTERY' WHEN SWITCHED ON EVEN IF CONNECTED TO THE MAIN; GREEN LED DOESN'T SWITCH ON POWER SUPPLY FAILURE". NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ERROR DETECTED BY HOSPITAL SERVICE ENGINEERS DURING EQUIPMENT ORDINARY CHECK. THE PUMP DISPLAYS 'SYSTEM RUNNING ON BATTERY' WHEN SWITCHED ON EVEN IF CONNECTED TO THE MAIN; GREEN LED DOESN'T SWITCH ON POWER SUPPLY FAILURE". NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231573 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown