BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    MDR report key: 19477344 · Received June 6, 2024

    Report

    Report Number
    2916596-2024-03581
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    October 27, 2016
    Report Date
    June 6, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010142
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q224-HF-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G4: THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA# PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE TOUCHSCREEN BUTTON ON THE SYSTEM MONITOR NOT FUNCTIONING PROPERLY WAS CONFIRMED. TROUBLESHOT THE SYSTEM MONITOR AND REPLACED THE MAIN CIRCUIT BOARD ASSEMBLY AND TOUCHSCREEN. ALSO REPLACED THE REAR HOUSING AND THE GREEN LIGHT EMITTING DIODE (LED) CABLE ASSEMBLY. PERFORMED ALL TESTS ON THE SYSTEM MONITOR WHICH PASSED. THE SYSTEM MONITOR WAS REPAIRED AND RETURNED TO THE CUSTOMER'S SITE. FUNCTIONAL TESTING PERFORMED ON THE RETURNED SYSTEM MONITOR PRINTED CIRCUIT BOARD (PCB) REVEALED THE COMPONENT FUNCTIONED AS INTENDED. THE SPECIFIC ROOT CAUSE OF THE EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. ADDITIONALLY, A DAMAGED DISPLAY INVERTER POWER CABLE WAS RETURNED TO THE PLEASANT FACILITY. INSPECTION OF THE PART REVEALED A BROKEN WIRE, AND A COMPROMISE OF THE OUTER CABLE INSULATION ACROSS MULTIPLE CONDUCTORS WAS OBSERVED. THE PART IS USED IN THE ASSEMBLY TO CONTROL THE DISPLAY BRIGHTNESS. ALTHOUGH THE PART WAS RETURNED DAMAGED, THE INVESTIGATION WAS UNABLE TO DETERMINE IF THE DAMAGED PART CONTRIBUTED TO THE REPORTED EVENT. 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 08 MAY 2024. THE SYSTEM MONITOR WAS RECEIVED INTO INVENTORY ON 19DEC2005. THE SYSTEM MONITOR SHIPPED ON 17MAR2006. THE SYSTEM MONITOR WAS MANUFACTURED ON 15DEC2005. TOUCHSCREEN PART NUMBER 101219. MAIN PCB ASSEMBLY PART NUMBER 101381. REAR HOUSING PART NUMBER 101228. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE II POWER MODULE INSTRUCTIONS FOR USE REVISION B STATES IF THE SYSTEM MONITOR DOES NOT FUNCTION PROPERLY, CONTACT THE COMPANY'S TECHNICAL SERVICE DEPARTMENT FOR ASSISTANCE. 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 CLINICAL SCREEN BUTTON ON THE SYSTEM MONITOR DID NOT RESPOND WELL WHEN TOUCHING THE BUTTON. A REPLACEMENT SYSTEM MONITOR WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7170 THORATEC® HEARTMATE®, SYSTEM MONITOR Ventricular (assist) bypass DSQ THORATEC CORPORATION 1286 44038 00813024010142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown