BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 5879518 · Received August 16, 2016

    Report

    Report Number
    1226181-2016-00400
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 21, 2016
    Report Date
    August 16, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. PHOTOMETER LAMP REPLACEMENT IS A CUSTOMER MAINTENANCE ACTION AND THE INJURY OCCURRED WHILE THE OPERATOR WAS CHANGING THE LAMP. THE LAMP REPLACEMENT WAS SUCCESSFUL AND THE INSTRUMENT IS WORKING AS EXPECTED. THE OPERATOR DID NOT SEEK ANY TREATMENT BEYOND FIRST AID AND RETURNED TO WORK AFTER THEIR FINGER WAS EXAMINED BY X-RAY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST AND STATED THAT AN OPERATOR OF A DIMENSION EXL 200 INSTRUMENT INJURED HER FINGER WHILE REPLACING A PHOTOMETER LAMP. TO REPLACE THE PHOTOMETER LAMP, THE OPERATOR MUST LOWER THE THERMAL CHAMBER AND WHEN THE LAMP HAS BEEN REPLACED THE CHAMBER SHOULD BE RAISED AGAIN UNTIL IT SEATS COMPLETELY AGAINST THE BASEPLATE. WHILE TRYING TO DO THIS, THE OPERATOR INADVERTENTLY PLACED HER FINGER BETWEEN THE EDGE OF THE THERMAL CHAMBER AND THE BASEPLATE, CRUSHING HER FINGER AND CAUSING IT TO BLEED. THE OPERATOR USED COLD WATER TO TREAT THE INJURY. AN X-RAY EXAMINATION SHOWED THAT THE FINGER BONES WERE NOT BROKEN. THE OPERATOR RETURNED TO WORK AFTER X-RAY EXAMINATION AND DID NOT SEEK ANY TREATMENT BEYOND FIRST AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532027 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1