BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA XE-90 CENTRIFUGE

    MDR report key: 4895827 · Received July 7, 2015

    Report

    Report Number
    3007448124-2015-00004
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(6) 2015. THE FSE REPLACED THE "BURNT OUT" THERMOELECTRIC HEATSINK AND TEST RAN THE INSTRUMENT TO VERIFY VACUUM AND COOLING SYSTEM PERFORMANCE. THE UNIT FUNCTIONS PROPERLY. THE CHARRED HEATSINK COMPONENT WAS CAUSED BY A DEFECTIVE TEM (THERMOELECTRIC MODULE) ON THE HEATSINK ASSEMBLY. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON REVISION OF THE FILED MDR THE PRODUCT CODE WAS CHANGED FROM KSO TO JQC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A D509 TEMPERATURE ERROR CODE (TEMPERATURE DIAGNOSTIC, OPEN OR SHORT CIRCUIT IN THE THERMOELECTRIC MODULE CIRCUIT) FROM AN OPTIMA XE-90 CENTRIFUGE, AND REQUESTED A SERVICE VISIT. NO SMOKE, FIRE, OR BURNING SMELL WAS REPORTED BY THE CUSTOMER. THERE WAS NO INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440245 OPTIMA XE-90 CENTRIFUGE CENTRIFUGE, BLOOD-BANK FOR IN VITRO DIAGNOSTIC USE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1