BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3062660 · Received April 17, 2013

    Report

    Report Number
    1226181-2013-00176
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED (B)(4). DURING TROUBLESHOOTING, THE CUSTOMER INFORMED THE TSC SPECIALIST THAT THE SMOKE HAD COME FROM THE HEAT TORCH. THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE HEAT SOURCE, WHICH THE CUSTOMER DID. THERE WAS NO DAMAGE OBSERVED TO THE INSTRUMENT DUE TO THE HEAT TORCH OVERHEATING, AND NO SMOKE WAS OBSERVED AFTER THE HEAT TORCH WAS REPLACED. THE CAUSE OF THE SMOKE COMING FROM THE DIMENSION EXL WITH LM INSTRUMENT WAS A MALFUNCTION OF THE HEAT TORCH. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION EXL WITH LM INSTRUMENT OBSERVED SMOKE COMING FROM THE DIAPHRAGM OF THE INSTRUMENT. THE OPERATOR RECEIVED A SLIGHT BURN WHEN HE UNLATCHED THE AREA. NO MEDICAL TREATMENT BEYOND FIRST AID WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166111 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1