BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 10482836 · Received September 2, 2020

    Report

    Report Number
    2134265-2020-12193
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729883302
    PMA / PMN Number
    K050006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS REPORTED FOR THE AMP NOT TURNING ON. VISUAL INSPECTION OF THE DEVICE REVEALED THAT IT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE. DURING FUNCTIONAL TESTING IT WAS CONFIRMED THAT THE AMPLIFIER WILL NOT TURN ON, THE LED POWER DID NOT LIGHT AND THE FAN DID NOT TURN ON. IT WAS ALSO REVEALED THAT 2 FUSES HAD CONTINUITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED HAT THE PROCEDURE WAS CANCELED. IT WAS REPORTED THAT A CLEARSIGN AMP, 80 WAS SELECTED FOR A PROCEDURE. IT WAS NOTED THAT THE AMP DID NOT TURN ON AND THE ISSUE WAS UNABLE TO BE RESOLVED. IT WAS NOT REPORTED IF THE PATIENT WAS SEDATED PRIOR TO THIS ISSUE BUT NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945700 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86640 1A959075 08714729883302

    Patients

    Seq Age Sex Outcome Treatment
    1