BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD EVOLUTION US

    MDR report key: 3770075 · Received January 28, 2014

    Report

    Report Number
    3006680097-2013-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    November 15, 2013
    Report Date
    November 21, 2013
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K070815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE DEVICE ARRIVED AT THD INC. HEADQUARTERS, IT HAS BEEN FOUND THAT THE CASE WAS DAMAGED. FURTHERMORE, ALWAYS IN THD INC. SITE, THE DEVICE HAS BEEN SWITCHED ON (BY PERSONNEL UNSKILLED IN THE PROCESS) BY FOLLOWING THE INSTRUCTIONS REPORTED IN THE USER MANUAL (REF. (B)(4)): THE DISPLAY SWITCHED ON WITHOUT SHOWING ANY CHARACTER. WE ARE WAITING TO RECEIVE THE DEVICE AT THE HEADQUATER OF THD SPA (ITALY), IN ORDER TO COMPLETE THE INVESTIGATION (THE DEVICE IS WAITING FOR CLEARANCE AT THE CUSTOMS).

    Description of Event or Problem · 1

    THE PATIENT WAS ANESTHETIZED AND PREPARED FOR THD PROCEDURE. WHEN EVERYTHING WAS READY, THE GENERATOR HAS BEEN SWITCHED ON, THE SCREEN WAS BLUE BUT NO WORDS APPEARED ON IT AND IT WAS NOT POSSIBLE TO START THE CASE. THEY TRIED TO TURN IT ON AGAIN BUT THEY HAD THE SAME PROBLEM. WHILE WAITING THAT THE SPECIALIST ARRIVED IN THE HOSPITAL WITH ANOTHER GENERATOR, THE ANESTHESIOLOGIST WOKE UP THE PATIENT. THEY PUT THE PATIENT BACK UNDER WHEN THE SPECIALIST DELIVERED THE SECOND GENERATOR. THE PATIENT RECEIVED ANESTHESIA TWICE IN ONE DAY. THE DELAY WAS ABOUT 45 MINUTES. THE CASE WENT WELL AND THE PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60538 THD EVOLUTION US NONE JAF THD SPA 700016A

    Patients

    Seq Age Sex Outcome Treatment
    1