BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG PRIMARY CONSOLE

    MDR report key: 3042206 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00383
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS CONNECTED TO A LEFT VENTRICULAR ASSIST DEVICE. THE DEVICE WAS FUNCTIONING ON BATTERY POWER AND STOPPED DURING PATIENT TRANSPORTATION. THE HOSPITAL STAFF REPORTED THAT THE BATTERY GAUGE SHOWED FULL BATTERY VOLTAGE AT THE TIME THE PUMP STOPPED. IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137910 CENTRIMAG PRIMARY CONSOLE DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102954

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention