BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYLINK

    MDR report key: 4201189 · Received October 27, 2014

    Report

    Report Number
    2517506-2014-00243
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE SMOKE WAS DUE TO A MALFUNCTION IN THE INSTRUMENT UNINTERRUPTIBLE POWER SUPPLY (UPS). THE CSE REPLACED THE UPS AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    SMOKE EMISSION WAS DETECTED ON A EASYLINK SYSTEM UNINTERRUPTIBLE POWER SUPPLY (UPS). THE UPS POWER WAS TURNED OFF TO STOP THE SMOKE EMISSION. THERE WERE NO REPORTS OF STAFF INJURY, DAMAGE TO PROPERTY OR IMPACT TO PATIENTS DUE TO THE SMOKE EMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682072 EASYLINK INFORMATICS SYSTEM JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. EASYLINK INFORMATICS SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1