BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 8054695 · Received November 9, 2018

    Report

    Report Number
    2517506-2018-00635
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 17, 2018
    Report Date
    December 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414593579
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2018-00635 ON 09-NOV-2018. ADDITIONAL INFORMATION (15-NOV-2018): SIEMENS FURTHER INVESTIGATED THE ISSUE TO DETERMINE THE CAUSE OF THE OPERATOR'S INJURY TO THE FINGER. SIEMENS DETERMINED THAT THE INJURY WAS POTENTIALLY DUE TO THE CUVETTE RING OR CUVETTE WHEEL SENSOR. WHEN THE OPERATOR WAS UNABLE TO SEAT THE THERMAL CHAMBER, SIEMENS INSTRUCTED THE OPERATOR TO LOWER THE CHAMBER AGAIN. THE OPERATOR WAS INJURED WHEN RAISING THE THERMAL CHAMBER AS HE ATTEMPTED TO RESEAT THE CHAMBER. THE DIMENSION EXL 200 INSTRUMENT OPERATOR'S GUIDE RECOMMENDS THE FOLLOWING FOR RAISING THE THERMAL CHAMBER: "RAISING THE THERMAL CHAMBER - CAUTION: DO NOT RAISE THE THERMAL CHAMBER BY LIFTING UP ON THE PLASTIC COMPONENTS WHERE THE AIR HOSE CONNECTS TO THE THERMAL CHAMBER. LIFT UP ON THE SIDE OR BOTTOM OF CHAMBER UNTIL THE THERMAL CHAMBER SEATS COMPLETELY AGAINST THE BASEPLATE." SIEMENS DETERMINED THAT THE OPERATOR DID NOT LIFT THE THERMAL CHAMBER USING THE BOTTOM OR SIDE AS RECOMMENDED IN THE OPERATOR'S GUIDE; THE OPERATOR WAS INJURED BECAUSE HE PLACED HIS HANDS ON TOP OF THE THERMAL CHAMBER, WHICH CAUSED HIS HAND TO BE SANDWICHED BETWEEN THE BOTTOM OF CUVETTE RING AND TOP EDGE OF THERMAL CHAMBER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AN OPERATOR OF AN DIMENSION EXL 200 INSTRUMENT SUSTAINED AN INJURY TO THE FINGER WHILE TROUBLESHOOTING THE DIMENSION EXL 200 INSTRUMENT WITH A SIEMENS CUSTOMER CALL CENTER (CCC) REPRESENTATIVE. SIEMENS INVESTIGATED THE EVENT AND DETERMINED THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS FROM THE CCC REPRESENTATIVE; SIEMENS TOLD THE OPERATOR TO PLACE THE PALM OF HIS FREE HAND ON THE THERMAL CHAMBER AND PUSH BACK; BUT NOT TO PUT FINGERS OVER THE TOP EDGE OF THE THERMAL CHAMBER. THE OPERATOR'S GUIDE RECOMMENDS THAT ALL LIDS SHOULD BE FULLY OPEN TO AVOID INJURY WHILE PERFORMING MAINTENANCE. THE OPERATOR'S METHOD IN HANDLING THE INSTRUMENT CONTRIBUTED TO THE OPERATOR'S INJURY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR OF AN DIMENSION EXL 200 INSTRUMENT SUSTAINED AN INJURY TO THE FINGER WHILE SEATING THE THERMAL CHAMBER ON THE INSTRUMENT AFTER REPLACING A SOURCE LAMP. THE OPERATOR WAS LOWERING THE THERMAL CHAMBER TO REPLACE THE OLD LAMP WHEN HE SUSTAINED THE INJURY; THE CUSTOMER CUT HIS INDEX FINGER ON THE THERMAL CHAMBER. HE WASHED THE CUT, APPLIED ANTIBIOTIC OINTMENT AND BANDAGED THE AFFECTED AREA. OPERATOR REPORTED THAT HE WENT TO THE EMERGENCY DEPARTMENT, BUT NO OTHER MEDICAL INTERVENTION WAS ADMINISTERED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE OPERATOR'S INJURY TO THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894494 DIMENSION EXL 200 DIMENSION EXL 200 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 00630414593579

    Patients

    Seq Age Sex Outcome Treatment
    1