BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6132017 · Received November 29, 2016

    Report

    Report Number
    1828100-2016-00767
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    January 27, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-06/05/2007-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED BY THE PRODUCT SURVEILLANCE TECHNICIAN (PST) AS PER LABORATORY REPORT. THE PST OBSERVED BLANK SCREEN AT BOOT UP AND INACCURATE TOUCH SCREEN RESPONSE. REPLACEMENT OF CUSTOMER INVERTER BOARD AND CUSTOMER TOUCH SCREEN RESTORED CENTRAL CONTROL MONITOR (CCM) FUNCTIONALITY. THE DEVICE WAS SENT TO SERVICE TO BE BROUGHT TO MANUFACTURER'S SPECIFICATIONS BEFORE RETURNING TO CLINICAL USE. THIS COMPLAINT IS RELATED TO MEDWATCH #1828100-2016-00653. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SENIOR QUALITY ASSURANCE TECHNICIAN FOUND THAT THE CENTRAL CONTROL MONITOR (CCM) HAS A DEFECTIVE TOUCH SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784616 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1