BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 16330171 · Received February 8, 2023

    Report

    Report Number
    3010532612-2023-00072
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 26, 2023
    Report Date
    January 26, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WAS AN AC3 DISPLAY HEAD (P/N: 33-0100-003 S/N: (B)(6). VISUAL INSPECTION OF THE DISPLAY HEAD AND DISPLAY CABLE WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE DISPLAY HEAD WAS INSTALLED ONTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED UP SUCCESSFULLY, AND NO ABNORMALITIES WAS NOTED ON THE SCREEN. THE SYSTEM HAD A NORMAL RESPONSE TO THE TOUCH SCREEN AND HARD KEYS. EACH HARD KEY WAS PRESSED MULTIPLE TIMES (WAIT FOR 30 SECONDS ON EACH PRESS); AND NO ALARMS OR ERRORS OCCURRED. ALL THE WAVEFORMS AND ICONS WERE DISPLAYED CORRECTLY. THE SCREEN WAS SUCCESSFULLY RECALIBRATED FOR BOTH HARD KEY AND SOFT KEY. PUMPING WAS INITIATED. THE PUMP WAS LEFT TO RUN FOR OVER AN HOUR WITH NO ISSUES. VISUAL INSPECTION OF THE DISPLAY HEAD INTERNAL HARDWARE WAS PERFORMED. ALL CABLES AND HARDWARE WERE PROPERLY SEATED, AND NO ABNORMALITIES WERE NOTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO R ELEASE. THE RISK IS ACCEPTABLE. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT OF "NOT RESPONSIVE TO TOUCH" IS NOT CONFIRMED. THE RETURNED DISPLAY HEAD PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    REPORTED AS "SCREEN NOT RESPONDING AND DESCRIBED AS 'SLOW TO RESPOND' OR TOTALLY NON-RESPONSIVE. LOCK SCREEN NOT ON. ALSO STATED THE PUMP IS INTERMITTENTLY PUMPING, AND HE CANNOT SEE THE WAVEFORMS. THERE HAVE BEEN SOME TRIGGER LOSS ALARMS AS WELL AS INSUFFICIENT TIME TO DEFLATE ALERTS. BATTERY CHARGING AND VOLTAGE 12.9. CONSOLE EXCHANGED". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "CRITICAL PRIOR TO EVENT". SEE ASSOCIATED MDR 3010532612-2023-00073.

    Description of Event or Problem · 0

    REPORTED AS "SCREEN NOT RESPONDING AND DESCRIBED AS 'SLOW TO RESPOND' OR TOTALLY NON-RESPONSIVE. LOCK SCREEN NOT ON. ALSO STATED THE PUMP IS INTERMITTENTLY PUMPING, AND HE CANNOT SEE THE WAVEFORMS. THERE HAVE BEEN SOME TRIGGER LOSS ALARMS AS WELL AS INSUFFICIENT TIME TO DEFLATE ALERTS. BATTERY CHARGING AND VOLTAGE 12.9. CONSOLE EXCHANGED". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "CRITICAL PRIOR TO EVENT". SEE ASSOCIATED MDR 3010532612-2023-00073.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168164 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN917285 N/A 10801902172065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown