BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 10977618 · Received December 9, 2020

    Report

    Report Number
    2134265-2020-17250
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729884897
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE CLEARSIGN II AMP WAS SELECTED TO BE USED IN A PROCEDURE. HOWEVER IT WAS NOTED THAT THAT DURING PREPARATION THE PHYSICIAN FOUND A CABLE CONNECTION ISSUE. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444884 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86620 1D832455 08714729884897

    Patients

    Seq Age Sex Outcome Treatment
    1