BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE SYSTEM MONITOR II

    MDR report key: 11870300 · Received May 24, 2021

    Report

    Report Number
    2916596-2021-02813
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    February 9, 2021
    Report Date
    May 24, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF THE SYSTEM MONITOR WITH A STARTUP ERROR (CHECKSUM), WAS CONFIRMED WHEN THE UNIT WAS EVALUATED BY TECHNICAL SERVICE (EDC). THE UNIT WAS REPAIRED BY REPLACING THE MAIN PCBA. THE REPAIRED SYSTEM MONITOR WAS TESTED AND RETURNED TO THE RENTAL/LOANER POOL. PER DEVICE SERVICE RECORDS, THE MAIN PCBA WAS INSTALLED IN THE SYSTEM MONITOR IN MAY 2008. A ROOT CAUSE FOR THE CHECKSUM ERROR AT STARTUP WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE SYSTEM MONITOR PN 101214 WAS BUILT IN DEC 2006. THE PACKAGED SYSTEM MONITOR (PN 1286A) WAS PLACED INTO INVENTORY ON DEC 14, 2006. THE UNIT WAS SHIPPED TO (B)(6) ON JAN 2007. THE UNIT WAS LAST RETURNED FROM RENTAL/LOANER USE ON APR 17, 2019. THE UNIT WAS SHIPPED TO THE CUSTOMER ON MAY 16, 2019. THE MAIN PCBA (PN 103433 REV A / SN: (B)(4) WAS INSTALLED INTO THE SYSTEM MONITOR IN MAY 2008. SETUP AND USE OF THE SYSTEM MONITOR WITH THE HEARTMATE POWER MODULE ARE DOCUMENTED IN THE HEARTMATE POWER MODULE INSTRUCTIONS FOR USE (IFU) - SETTING UP THE SYSTEM MONITOR FOR USE WITH THE POWER MODULE), THE HEARTMATE II LVAS IFU (SYSTEM MONITOR SETUP) AND THE HEARTMATE 3 LVAS IFU (SYSTEM MONITOR SETUP). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM MONITOR DID NOT COMPLETE THE BOOTING PROCESS. THERE WAS AN ERROR MESSAGE 'CRC CHECK SUM ERROR CODE: 13 SYSTEM HALTED!' APPEARED ON THE SCREEN. RE-BOOTING DIDN'T SOLVE THE ISSUE. THE UNIT WAS EXCHANGED. UPON INVESTIGATION OF THE RETURNED DEVICE, AND ISSUE WITH THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767400 HEARTMATE SYSTEM MONITOR II VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 1286A

    Patients

    Seq Age Sex Outcome Treatment
    1