BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3834036 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01190
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APS1 CARD, REINSTALLATION OF THE COMPUTER'S WINDOWS (OPERATING) SYSTEM. IN CONCLUSION, REINSTALLATION OF THE COMPUTER'S WINDOWS (OPERATING) SYSTEM AND REPLACEMENT OF THE APS1 (ZAP OR BURN CIRCUIT) CARD RESOLVED THE REPORTED ISSUES. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED THE INSTRUMENT COMPUTER DID NOT RESPOND AND GENERATED AN EXECUTION SYSTEM ERROR (EXE ERROR) MESSAGE INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AND DISCOVERED A BLOCKED WHITE BLOOD CELL (WBC) APERTURE AND NO ZAP APERTURE VOLTAGE. THE FSE REINSTALLED THE COMPUTER'S WINDOWS (OPERATING) SYSTEM TO RESOLVE THE COMPUTER LOCK-UP ISSUE AND REPLACED THE APS1 (ZAP OR BURN CIRCUIT) CARD TO RESOLVE THE ZAP APERTURE ISSUE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED ASSOCIATED WITH THIS EVENT. PATIENT CARE WAS NOT IMPACTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311459 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1