BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 8730463 · Received June 25, 2019

    Report

    Report Number
    1061932-2019-01672
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590701574
    PMA / PMN Number
    K140911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE INSTALLING THE INSTRUMENT THE FSE INJURED HIS HAND. THE FLAP BEHIND THE FLOOR STAND (COMPRESSOR SIDE) OF THE INSTRUMENT WAS JAMMED AND OPENED JERKILY. THE FSE WAS ABLE TO COMPLETE THE INSTRUMENT INSTALL PROCESS. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    IN THE PROCESS OF INSTALLING THE DXH 900 HEMATOLOGY INSTRUMENT AT THE CUSTOMER SITE, THE FIELD SERVICE ENGINEER (FSE) INJURED THE INDEX FINGER ON HIS LEFT HAND WHEN A FLAP IN THE REAR AREA OF THE INSTRUMENT OPENED JERKILY. THE FSE WAS TREATED BY A DOCTOR. THE HAND WAS X-RAYED AND THE FINGER WAS FOUND TO BE BRUISED AND FRACTURED. THE INJURY DID NOT REQUIRE STITCHES BUT THE FINGER WAS STABILIZED WITH A RAIL/SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524438 UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND 15099590701574

    Patients

    Seq Age Sex Outcome Treatment
    1 Other