BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 11922515 · Received June 2, 2021

    Report

    Report Number
    2134265-2021-07143
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE USING A LS PRO AMPLIFIER THEY RECEIVED AN ERROR MESSAGE. THEY WERE UNABLE TO RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELED. IT WAS REPORTED THE PATIENT IS STABLE AND THAT THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE SEDATION STATUS OF THE PATIENT AT THE TIME THE PROCEDURE WAS CANCELED IS UNKNOWN DESPITE GOOD FAITH ATTEMPTS TO OBTAIN THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822477 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86620

    Patients

    Seq Age Sex Outcome Treatment
    1