BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR A3600

    MDR report key: 9932999 · Received April 7, 2020

    Report

    Report Number
    3010825766-2020-00004
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Report Date
    April 7, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAS BEEN INVESTIGATED BY THE DISTRIBUTOR FSE, BUT IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE WHICH TRIGGERED THE FLAME. THE POWER SUPPLY IS CERTIFIED FOR THE ELECTRICAL SAFETY AND THE FLAME AUTO-EXTINGUISHED, AS EXPECTED. THE DAMAGED POWER SUPPLY HAS BEEN REPLACED. THERE ARE NO PREVIOUS SIMILAR OCCURRENCES REPORTED FROM THE FIELD FOR THIS COMPONENT, SO THE EVENT HAS BEEN EVALUATED AS A SINGLE OCCURRENCE. THE AUTOMATION SYSTEM IS NOW PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR FSE ONSITE SMELLED SMOKE NEAR THE STORAGE RETRIEVE MODULE AND RIGHT AFTER THE TRACK WENT DOWN WITH A POWER SUPPLY ERROR. INVESTIGATING THE ISSUE, THE FSE FOUND THE 24V POWER SUPPLY DAMAGED WITH EVIDENCE OF FIRE. NO VISIBLE SMOKE NOR FLAMES WERE SEEN: THE FIRE WAS ALREADY AUTO EXTINGUISHED WHEN THE FSE FOUND THE DAMAGED POWER SUPPLY. NO ONE IN THE LABORATORY WAS NEAR TO THE POWER SUPPLY WHEN THE EVENT OCCURRED AND NO ONE GOT INJURED. NO OTHER COMPONENTS WERE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396772 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1