BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 14044745 · Received April 7, 2022

    Report

    Report Number
    2134265-2022-04125
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729885849
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE LABSYSTEM PRO CLEARSIGN AMPLIFIER POWER SUPPLY "BLEW UP, AND THAT IT APPEARED TO HAVE EXPLODED". THE ISSUE OCCURRED DURING TRAINING SO THERE WAS NO PATIENT INVOLVEMENT. THE TRAINING WAS DISCONTINUED. THE AMPLIFIER IS NOT EXPECTED TO BE RETURNED AS IT WAS SERVICED ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165831 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86640 1D106124 08714729885849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown