BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 17670484 · Received September 1, 2023

    Report

    Report Number
    2124215-2023-47159
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729885948
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CORRECTION H6 EVALUATION CONCLUSION CODES: CAUSE NOT ESTABLISHED > CAUSE TRACED TO COMPONENT FAILURE. THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, HOWEVER, THE LABSYSTEM PRO WAS EVALUATED BY A BOSTON SCIENTIFIC FIELD SERVICE ENGINEER ONSITE. CHECKED CMOS BATTERY FOUND VOLTAGE AT 2.760. REPLACED CMOS BATTERY VOLTAGE ON NEW BATTERY WAS 3.293 V. UPGRADED SOFTWARE TO 4.2. TESTED UNIT, SYSTEM PASSED ALL FUNCTIONAL TESTS AND IS READY FOR USE. ANALYSIS WAS ABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, A LABSYSTEM PRO WAS SELECTED FOR USE. UNIT FROZE DURING THE CASE. ISSUE OCCURRED ABOUT IN THE MIDDLE OF A 3 HOUR CASE. ACCOUNT WAS PACING FROM THE BEGINNING. TROUBLESHOOTING WITH THE ACCOUNT EXTENDED TIMING FOR PACING FROM 45 MINUTES TO 60 MINUTES. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS OCCURRED. UNIT WILL NOT BE RETURNED SINCE IT WAS REPAIRED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PROCEDURE, A LABSYSTEM PRO WAS SELECTED FOR USE. UNIT FROZE DURING THE CASE. ISSUE OCCURRED ABOUT IN THE MIDDLE OF A 3 HOUR CASE. ACCOUNT WAS PACING FROM THE BEGINNING. TROUBLESHOOTING WITH THE ACCOUNT EXTENDED TIMING FOR PACING FROM 45 MINUTES TO 60 MINUTES. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS OCCURRED. UNIT WILL NOT BE RETURNED SINCE IT WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190266 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86620 1D911712 08714729885948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown