BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2971372 · Received February 4, 2013

    Report

    Report Number
    1828100-2013-00147
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE SERVICE REPAIR TECHNICIAN (SRT). THE SRT REPLACED THE PROGRAM DISK-ON CHIP COMPONENT AND THE UNIT WAS BROUGHT TO MANUFACTURERS SPECIFICATIONS AND RETURNED TO THE CLINICAL USE. 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

    UPON RECEIPT OF THE DEVICE, THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT A NEW PROGRAM DISK-ON CHIP, VERSION (B)(4) FAILED (AN OUT-OF-BOX FAILURE). THE REPORTED ISSUE OCCURRED AFTER INSTALLING THE NEW DISK-ON CHIP (DOC) COMPONENT ON THE LAN INTERFACE (IF) BOARD. DURING POWER UP THE SCREEN WOULD NOT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47270 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 815272

    Patients

    Seq Age Sex Outcome Treatment
    1