BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 1912327 · Received November 3, 2010

    Report

    Report Number
    2916596-2010-00282
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 8, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NOT SPECIFIED DURING THE INITIAL CONTACT TO THE MFR, ADD'L INFO RECEIVED VIA A MEDWATCH REPORT SUBMITTED BY THE HOSPITAL STATED THAT THE DUAL DRIVE CONSOLE WAS NOT EMPTYING CORRECTLY, WAS LOOSING PRESSURE AND A HOSE ATTACHED TO THE COMPRESSOR WAS FOUND TO BE BROKEN. REPLACEMENTS PARTS WERE ORDERED AND THE UNIT WILL BE SERVICED BY THE MFR'S TRAINED TECHNICAL SERVICE PERSON. 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

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE DUAL DRIVE CONSOLE (DDC) WAS LOOSING PRESSURE. THE PT WAS SWITCHED TO A BACK UP DUAL DRIVE CONSOLE (DDC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC) VENTRICULAR ASSIST DEVICE SYSTEM (DDC) DSQ THORATEC CORP. 10025-2600-005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention