BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 17558648 · Received August 16, 2023

    Report

    Report Number
    2124215-2023-43068
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 7, 2023
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    DRQ
    UDI-DI
    08714729884897
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURN FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE EVENT REPORTED, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CLEARSIGN II AMP WAS NOT RETURNED AND EVALUATED BY BOSTON SCIENTIFIC, BUT THE ON-SITE SERVICE WAS REVIEWED DURING THE COURSE OF THIS INVESTIGATION, THE DEVICE WAS TESTED MANY TIMES RELATED TO THE FAILURE REPORTED, AND THE MACHINE STARTED NORMALLY, ALSO THE SOFTWARE IS RUNNING NORMALLY. COMMUNICATION WITH THE COSTUMER WAS MADE AND THE AMPLIFIER GOT MAINTENANCE, SO THE DEVICE WAS TESTED AGAIN, AND IT STARTED NORMALLY. THE REPORTED ALLEGATION IS NOT CONFIRMED.

    Description of Event or Problem · 0

    DURING PROCEDURE, AN LABSYSTEM PRO CLEARSIGN II AMP, 80 CHANNELS WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER AND THE SOFTWARE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED. THE DEVICE WON'T BE RETURNED SINCE THE ISSUE WAS SOLVED ON SITE, THE SOFTWARE RAN NORMALLY, AND THE AMPLIFIER WAS MAINTAINED AND THERE ARE NOT DEVICE COMPONENTS TO BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

    Description of Event or Problem · 0

    DURING PROCEDURE, AN LABSYSTEM PRO CLEARSIGN II AMP, 80 CHANNELS WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER AND THE SOFTWARE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED. THE DEVICE WON'T BE RETURNED SINCE THE ISSUE WAS SOLVED ON SITE, THE SOFTWARE RAN NORMALLY, AND THE AMPLIFIER WAS MAINTAINED AND THERE ARE NOT DEVICE COMPONENTS TO BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893814 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ EP TECHNOLOGIES, INC. 86620 1D261371 08714729884897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown