BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2471086 · Received February 28, 2012

    Report

    Report Number
    1061932-2012-00698
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE UPS CAUGHT FIRE WHEN THE HOSPITAL'S GENERATOR TURNED ON. THE COULTER LH 500 HEMATOLOGY ANALYZER WAS NOT AFFECTED BY THE FIRE. THE UPS POWERVAR WILL BE RETURNED TO BECKMAN COULTER, INC FOR EVALUATION. ON (B)(4) 2012, THE UPS WAS REPLACED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SUBMISSION INDICATED THAT "THE UPS POWERVAR WILL BE RETURNED TO BECKMAN COULTER, INC FOR EVALUATION." SINCE THE DATE OF MDR FILING, THE RETURNED PART WAS EVALUATED BY BECKMAN COULTER INC. BECKMAN COULTER INC. EVALUATION OF THE RETURNED PART INDICATED THAT POINT OF FAILURE DAMAGE WAS EXTENSIVE. THE FIRE OCCURRED AT THE POINT OF CONNECTION OF THE BATTERIES TO THE PRINTED CIRCUIT BOARD. EVIDENCE OF A FIRE WAS CONFIRMED HOWEVER THE ROOT CAUSE OF THE FIRE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORT A POTENTIAL HAZARD WHEN THE UPS (UNINTERRUPTED POWER SOURCE) POWERVAR OF THE COULTER LH 500 HEMATOLOGY ANALYZER CAUGHT ON FIRE. THE FIRE ALARM WAS ACTIVATED AND THE AREA EVACUATED. THE LABORATORY PERSONNEL USED A FIRE EXTINGUISHER TO PUT OUT THE FIRE. THE FIRE DEPARTMENT ARRIVED AND INSPECTED THE LABORATORY AND ALLOWED PERSONNEL TO REENTER THE LABORATORY. ONE OPERATOR WAS SLIGHTLY BURNED, AND WAS SEEN BY A DOCTOR. THE OPERATOR COMPLETED HER SHIFT, AND ANY FORM OF TREATMENT IS UNKNOWN. AS OF (B)(6) 2012, THE OPERATOR WAS FINE AND THE BURN WAS SUPERFICIAL. THERE WERE NO SERIOUS INJURIES REPORTED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, OR AFFECT TO OPERATOR SAFETY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1