BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR A3600

    MDR report key: 21804060 · Received April 9, 2025

    Report

    Report Number
    3010825766-2025-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 23, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INPECO HAS REQUESTED THE RETURN OF THE DAMAGED ELECTRICAL COMPONENTS TO INVESTIGATE THE ISSUE. THERE ARE NO PREVIOUS COMPLAINTS REGARDING FLAMES OR EVIDENCE OF FIRE FOR THE CABLE 0C00007865. ACCELERATOR A3600 IS IN COMPLIANCE WITH IEC-UL 61010-1. THE ITEMS THAT CONSTITUTE THE CABLE 0C00007865 ARE INCLUDED IN THE CERTIFICATE FOR IEC-UL 61010-1 AND HAVE BEEN EVALUATED SUITABLE FOR THE FORESEEN USE. IN CASE OF FIRE, THE FLAMES SELF-EXTINGUISH WITHIN 30 SECONDS ONCE THE HEAT SOURCE IS REMOVED OR THE COMBUSTIBLE MATERIAL IS DEPLETED. ACCORDING TO INPECO ELECTRICAL SCHEMA, THE CABLE 0C00007865 SHOULD BE DIRECTLY CONNECTED TO THE MAIN POWER, THE ADDITIONAL CABLE AND THE MULTISOCKET USED IN THIS LABORATORY WERE NOT PROVIDED BY INPECO.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED ON APRIL 9TH, 2025 (3010825766-2025-00002). ADDITIONAL INFORMATION: THE BURNT CABLES WERE DISCARDED BY THE DISTRIBUTOR, SO IT WAS NOT POSSIBLE TO FURTHER INVESTIGATE THE ISSUE. BASED ON THE PROVIDED PHOTOS, THE ADDITIONAL CABLE CONNECTED TO INPECO CABLE 0C00007865 SEEMS TO BE THE MOST DAMAGED ONE. THIS CABLE WAS SUPPLIED TO THE DISTRIBUTOR NOT BY INPECO BUT BY A 3RD PARTY ELECTRICAL COMPANY. THE CABLE 0C00007865 IS CONFIRMED TO BE ADEQUATE. THE INVESTIGATION HAS NOT HIGHLIGHTED THE NEED OF ANY DESIGN CHANGE ON THE INPECO'S PRODUCT.

    Description of Event or Problem · 0

    A NON-US CUSTOMER REPORTED HE NOTICED FLAMES IN THE ACCELERATOR A3600 TRACK NEAR THE STORAGE MODULE #1. THE FLAMES WERE EXTINGUISHED BY CUSTOMER USING CO2 EXTINGUISHER. THE PLUG AND CABLE (INPECO PN 0C00007865) OF THE STORAGE MODULE REFRIGERATOR AND THE CONNECTED SOCKET AND CABLE (NOT PROVIDED BY INPECO) WERE MELTED. THE DISTRIBUTOR FIELD SERVICE ENGINEER UNPLUGGED THE CABLES FROM THE MAIN POWER AND REMOVED IT FROM THE TRACK. NO INJURIES HAVE BEEN REPORTED AS CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421345 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown