BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 3964685 · Received June 25, 2014

    Report

    Report Number
    2916596-2014-00997
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE PRIMARY CONSOLE IS NOT KNOWN TO THE MANUFACTURER AS THE DEVICE IS NOT LABELED FOR SINGLE USE. THE SUSPECT PRIMARY CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS BEING SUPPORTED WITH A VENTRICULAR ASSIST DEVICE FOR ACUTE SUPPORT. THE CENTER REPORTED THAT THE UNIT'S CONSOLE SCREEN WENT BLANK. NO FLOW. THE HOSPITALS SWITCHED THE PT TO THE BACKUP CONSOLE. WHEN THE PRIMARY CONSOLE WAS OFF OF THE PT. THE CENTER TURNED THE CONSOLE PACK ON, AND IT SEEMED TO WORK FINE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370575 THORATEC CENTRIMAG PRIMARY CONSOLE DWA: CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH 102954 000131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention