BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXA

    MDR report key: 22056608 · Received May 20, 2025

    Report

    Report Number
    3006655511-2025-00004
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JJE
    UDI-DI
    15099590720599
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER QUALITY ASSURANCE (QA) REVIEWED THE SERVICE NOTES OF THE EVENT. THE FSE REPORTED PERFORMING THE TASK, "REPLACE GROUNDING CABLE C79860 OF THE ECSD," PER SECTION 12.18.39 OF THE CURRENT VERSION DXA SERVICE MANUAL. THE FSE FOUND THEMSELVES CONFINED WHILE ATTEMPTING TO ACCESS A SERVICE AREA. CUSTOMER TECHNICAL SUPPORT (CTS) NOTES CORROBORATE THE NEED FOR INTERVENTION TO FREE THE FSE. IMMEDIATE ACTION TAKEN WAS PROVIDING MEDICAL TREATMENT FOR THE FSE'S INJURY. THE FSE RECEIVED STITCHES AT THE EMERGENCY ROOM. A SERVICE SME (SUBJECT MATTER EXPERT) REVIEWED THE RELEVANT SECTION AND FOUND NO INAPPROPRIATE INSTRUCTIONS. THE PROBABLE CAUSE IS DETERMINED AS USE ERROR AS THE FSE ENTERED A CONFINED SPACE WITHIN THE ECSD TO GAIN BETTER ACCESSIBILITY FOR SERVICING THE INSTRUMENT AND BECAME STUCK. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. G1: PHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    AN INCIDENT WAS REPORTED INVOLVING THE DXA ENVIRONMENTAL CONTROLLED STORAGE UNIT (ECSD). DURING SERVICING, THE FIELD SERVICE ENGINEER (FSE) BECAME TRAPPED WHEN THEIR HEAD GOT STUCK IN A TIGHT SPACE WITHIN THE ECSD. THE FSE SUSTAINED AN INJURY WHEN THEIR HEAD BECAME STUCK, LEADING TO A CUT ON THEIR EAR. THIS INJURY REQUIRED MEDICAL ATTENTION AND STITCHES AT AN EMERGENCY ROOM. THERE WERE NO REPORTS OF HARM TO A PATIENT, OPERATOR, OR ANY OTHER PERSON BEYOND THE FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12586 DXA ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER BIOMEDICAL GMBH ASSY INSTRUMENT ECSD 13K ? STOR 15099590720599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other