BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 3817937 · Received April 2, 2014

    Report

    Report Number
    2916596-2014-00509
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE PRIMARY CONSOLE IS NOT KNOWN TO THE MFR AS THE DEVICE IS NOT LABELED FOR SINGLE USE. THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSP'S BIOMEDICAL ENGINEER REPORTED THAT A BURNING SMELL WAS COMING FROM THE PRIMARY CONSOLE. THE UNIT WAS REMOVED FROM SERVICE. THERE WAS NOT A PT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199803 THORATEC CENTRIMAG KFM: CENTRIMAG PRIMARY CONSOLE KFM THORATEC SWITZERLAND GMBH 1ST GENERATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention