BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 ANALYZER (W/O CAP PIERCER)

    MDR report key: 2232435 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04797
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND INSPECTED THE INSTRUMENT BEFORE BOOT UP OR RESTORING POWER AND CHECKED COOLING FANS BEHIND INSTRUMENT. FSE DID NOT OBSERVE ANY APPARENT PROBLEM OR SIGNS OF BAD MOTORS. FSE WAS UNABLE TO BOOT UP THE INSTRUMENT AND THE CUSTOMER INFORMED FSE THAT THE HOSPITAL EXPERIENCED MAJOR POWER FAILURES. FSE ATTEMPTED TO TROUBLESHOOT POWER SUPPLIES (PS) AND ATTEMPTED TO CHANGE PS CABLING BUT WAS UNSUCCESSFUL IN DOING SO AND HENCE ORDERED NEW POWER SUPPLIES. FSE WENT BACK ON-SITE (B)(4) 2011, REPLACED ALL PS AND BOOTED UP INSTRUMENT. FSE THEN PRIMED AND RELOADED REAGENTS. THE CUSTOMER RAN QC AND CALIBRATED ALL REQUIRED CHEMISTRIES WITH NO ISSUES NOTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A BURNING SMELL AT THE BACK OF THE SYNCHRON LX20 ANALYZER. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 ANALYZER (W/O CAP PIERCER) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1