BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3202214 · Received June 28, 2013

    Report

    Report Number
    1828100-2013-00610
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REPRESENTATIVE (FSR) RETURNED THE SUSPECT BATTERIES, POWER MANAGER BOARD AND DATA LOGS TO THE MFR FRO FURTHER EVALUATION. THE DATA LOG ANALYSIS CONFIRMED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE PERFUSION SYSTEM WOULD NOT BOOT UP ON BATTERY, AS THE BATTERIES WERE DEAD. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295932 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1