BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6-MI CENTRIFUGE

    MDR report key: 6053402 · Received October 25, 2016

    Report

    Report Number
    3007448124-2016-00018
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE FOUND THAT THE INSTRUMENT HAD CAUGHT FIRE BUT WAS NOT ABLE TO DETERMINE A CAUSE. THE FSE NOTICED ALL THE ELECTRONIC COMPONENTS IN THE CENTRIFUGE WERE DAMAGED. THE FSE RETURNED THE INSTRUMENT FOR FURTHER EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE J6-MI CENTRIFUGE CAUGHT FIRE INTERNALLY. PER THE FIELD SERVICE ENGINEER (FSE) THE INSTRUMENT WAS SITTING IDLE AND WAS NOT BEING USED WHEN IT CAUGHT FIRE. THE INCIDENT TRIGGERED THE FIRE ALARM. THE FIRE DEPARTMENT WAS NOT CALLED AND THE CUSTOMER DID NOT REQUIRE A FIRE EXTINGUISHER. THERE WAS NO DEATH OR SERIOUS INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706786 J6-MI CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1