BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER

    MDR report key: 20306967 · Received September 25, 2024

    Report

    Report Number
    2124215-2024-60261
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 2, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729884941
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CLEARSIGN II AMPLIFIER WAS EVALUATED BY BOSTON SCIENTIFIC DUE TO NOT FUNCTIONING. EQUIPMENT ANALYSIS WAS PREFORMED AND THE AMPLIFIER PASSED FUNCTIONAL TESTING. NO PROBLEM WAS DETECTED. EQUIPMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. BASED ON ALL THE AVAILABLE INFORMATION THE ULTIMATE CAUSE OF THE EVENT THAT LED TO THE PROCEDURE CANCELLATION WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING AN EVENT, THE LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER WAS NOT FUNCTIONING. THE AMPLIFIER WAS STOPPED RESPONDING MID-PROCEDURE. IT WAS NOTED THAT HEPARINE SALINE FLUID SPLASHED ONTO ELECTRICAL EQUIPMENT PENDANT AND POTENTIALLY ENTERED A POWER SOCKET AND CIRCUIT BREAKER, THUS, LOSING POWER TO ALL EQUIPMENT. THE EQUIPMENT WAS REBOOTED WITHOUT ISSUES EXCEPT FOR THE CLEARSIGN AMPLIFIER. CONNECTION BETWEEN WORKSTATION COULD NOT BE RESTORED DESPITE ALL TROUBLESHOOTING SUGGESTED BY TECHNICAL SUPPORT. DUE TO THIS THE PROCEDURE WAS CANCELLED. PATIENT HAD BEEN SEDATED AT THE TIME OF CANCELLATION.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING AN EVENT, THE LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER WAS NOT FUNCTIONING. THE AMPLIFIER WAS STOPPED RESPONDING MID-PROCEDURE. IT WAS NOTED THAT HEPARINE SALINE FLUID SPLASHED ONTO ELECTRICAL EQUIPMENT PENDANT AND POTENTIALLY ENTERED A POWER SOCKET AND CIRCUIT BREAKER, THUS, LOSING POWER TO ALL EQUIPMENT. THE EQUIPMENT WAS REBOOTED WITHOUT ISSUES EXCEPT FOR THE CLEARSIGN AMPLIFIER. CONNECTION BETWEEN WORKSTATION COULD NOT BE RESTORED DESPITE ALL TROUBLESHOOTING SUGGESTED BY TECHNICAL SUPPORT. DUE TO THIS THE PROCEDURE WAS CANCELLED. PATIENT HAD BEEN SEDATED AT THE TIME OF CANCELLATION. IT WAS FURTHER REPORTED THAT A WORK ORDER WAS PERFORMED ONSITE. THE UNIT WAS TURNED ON AND CONFIRMED TO BE FAULTY. THE SOFTWARE WAS NOTE ABLE TO COMMUNICATE WITH THE AMPLIFIER. A REFURBISHED CLEARSIGN AMPLIFIER WAS CONNECTED AND COMMUNICATED PROPERLY WITH THE PC UNIT SOFTWARE. THE UNIT PASSED FUNCTIONAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243301 LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86620 1D911086 08714729884941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown