BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMATEK 2000

    MDR report key: 4480312 · Received February 3, 2015

    Report

    Report Number
    2432235-2015-00051
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 21, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KPA
    PMA / PMN Number
    K771559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 2432235-2015-00051 ON (B)(4) 2015 AND SUPPLEMENTAL MDR 2432235-2015-00051_S1 ON (B)(4) 2015. ADDITIONAL INFORMATION ((B)(6) 2015): BASED ON THE INVESTIGATION DETAILS AND EXAMINATION OF THE RETURNED SYSTEM AND FAILED COMPONENTS, SIEMENS DETERMINED THAT THERE WAS NO ACTUAL FIRE AND ONLY SMOKE WAS EMITTED FROM THE SYSTEM DUE TO THE TWO CAPACITOR COMPONENTS THAT FAILED. THE MELTED APPEARANCE ON THE COVER WAS DETERMINED TO BE THE BLACK MATERIAL THAT WAS OUT-GASSED FROM THE FAILED CAPACITORS AND THAT LEAKED OUT ONTO THE NEARBY COMPONENTS. SIEMENS COULD NOT SEE ANY TRACES OF OPEN FLAMES AND NONE OF THE COMPONENTS IN THE VICINITY WERE MELTED. IN ADDITION, THE POWER SUPPLY IS UL LISTED SO THE POWER SUPPLY BOARD IS INFLAMMABLE AND THE METAL BOX THAT CONTAINS THE POWER SUPPLY IS ALSO INFLAMMABLE. THE CUSTOMER RECEIVED ANOTHER HEMATEK 2000 INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR 2432235-2015-00051 ON (B)(4) 2015. ADDITIONAL INFORMATION ((B)(6) 2015): SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE CAUSE OF THE EVENT IS A DEFECTIVE POWER SUPPLY PCB, WHICH WAS ON A HEMATEK 2000 INSTRUMENT THAT WAS USED WELL BEYOND EXPECTED OPERATING LIFE. THE CUSTOMER WAS SENT A DIFFERENT HEMATEK 2000 INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS REQUESTED THAT THE CUSTOMER RETURN THE HEMATEK 2000 SYSTEM FOR INVESTIGATION AND/OR REPAIR. A DIFFERENT HEMATEK 2000 WAS SENT TO THE CUSTOMER. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED AND SMELT SMOKE COMING FROM THE BACK OF A HEMATEK 2000 SYSTEM ABOUT AN HOUR AFTER POWERING IT ON IN THE MORNING AND PERFORMING THE DAILY MAINTENANCE. THE CUSTOMER DETERMINED A BOARD ON THE UNIT CAUGHT FIRE. THE CUSTOMER SAFELY DISCONNECTED THE SYSTEM FROM THE POWER SUPPLY. THERE WERE NO INJURIES REPORTED, DAMAGE TO PROPERTY OR IMPACT TO PATIENT RESULTS DUE TO THE SMOKE COMING FROM THE BACK OF THE HEMATEK 2000 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78232 HEMATEK 2000 HEMATEK 2000 KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. HEMATEK 2000

    Patients

    Seq Age Sex Outcome Treatment
    1