BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    MDR report key: 19447505 · Received June 3, 2024

    Report

    Report Number
    2916596-2024-03364
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    March 4, 2013
    Report Date
    June 3, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010852
    PMA / PMN Number
    P060040
    Removal / Correction Number
    FA-Q224-HF-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SYSTEM MONITOR CONFIRMED THE REPORTED EVENT OF THE SCREEN HAVING A WHITE LINE AND THE GLOW IS DIFFERENT. THE UNIT'S LIQUID CRYSTAL DISPLAY (LCD) PANEL ASSEMBLY WAS DISCOVERED TO BE FAULTY. THE SYSTEM MONITOR WAS REPAIRED AND RETURNED TO THE CUSTOMER'S SITE. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO FURTHER ADDRESS THE ISSUES RELATED TO THE SYSTEM MONITOR ATYPICAL SCREEN BEHAVIOR. THE DEVICE IS INCLUDED IN THE SYSTEM MONITOR ATYPICAL SCREEN BEHAVIOR ADVISORY ISSUED BY ABBOTT ON (B)(6) 2024. THE SYSTEM MONITOR WAS RECEIVED INTO INVENTORY ON (B)(6) 2013. THE SYSTEM MONITOR SHIPPED TO THE CUSTOMER ON (B)(6) 2013. THE UNIT WAS MANUFACTURED (B)(6) 2013. LCD DISPLAY PANEL WAS PART NUMBER 101292, LOT NUMBER 121786. HEARTMATE II POWER MODULE INSTRUCTIONS FOR USE REVISION B STATES IF THE SYSTEM MONITOR DOES NOT FUNCTION PROPERLY CONTACT THORATEC'S TECHNICAL SERVICE DEPARTMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM MONITOR SCREEN HAD A WHITE LINE APPEARING AND THE GLOW WAS DIFFERENT. THE CONTACTS OF THE CABLES WERE INSPECTED AND FOUND TO BE SECURED. THE SYSTEM MONITOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593960 THORATEC® HEARTMATE®, SYSTEM MONITOR Ventricular (assist) bypass DSQ THORATEC CORPORATION 1286A-US 122735 00813024010852

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male