BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    MDR report key: 19481010 · Received June 6, 2024

    Report

    Report Number
    2916596-2024-03664
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    December 13, 2019
    Report Date
    June 6, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010852
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q224-HF-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT RESPONDING TO TOUCH, WAS NOT CONFIRMED WHEN THE SYSTEM MONITOR WAS EVALUATED BY TECHNICAL SERVICE. THE UNIT OPERATED PROPERLY WHEN TOUCH COMMANDS WERE PERFORMED. HOWEVER, A DAMAGED CARD READER WAS FOUND. THE CARD READER HAD A BENT PIN THAT PREVENTED DATA CARDS FROM BEING PROPERLY INSERTED. THE DATA CARD READER IS PART OF THE MAIN PRINTED CIRCUIT BOARD (PCB) ASSEMBLY; THE MAIN PCB ASSEMBLY WAS REPLACED. THE REPAIRED UNIT WAS TESTED AND RETURNED TO THE CUSTOMER. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO FURTHER INVESTIGATE 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 REPORTED EVENT AND SUBSEQUENT INVESTIGATION DO NOT INDICATE AN ISSUE WITH THE MANUFACTURE OF THE PRODUCT. THE SYSTEM MONITOR (PART NUMBER 101214) WAS BUILT IN DEC2005. THE PACKAGED SYSTEM MONITOR (PART NUMBER 1286A) WAS PLACED INTO INVENTORY ON 19DEC2005. THE UNIT WAS SHIPPED TO THE CUSTOMER ON 21FEB2006. THE UNIT WAS LAST SERVICED ON 22FEB2017 ¿ SOFTWARE VERSION 7.32 UPGRADE. THE MAIN PCB ASSEMBLY (PCBA) (PART NUMBER 100981 REV A / SERIAL NUMBER: (B)(6) WAS INSTALLED WHEN THE UNIT WAS BUILT (DEC2005). 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'S TOUCH SCREEN DID NOT WORK AND MAY HAVE NEEDED RECALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129081 THORATEC® HEARTMATE®, SYSTEM MONITOR Ventricular (assist) bypass DSQ THORATEC CORPORATION 1286A-US 44038 00813024010852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown