BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 7667070 · Received July 6, 2018

    Report

    Report Number
    2517506-2018-00409
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 6, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT, THE CSE REMOVED JAMMED FLEXES FROM THE WASTE CHUTE AND ALIGNED REAGENT SERVER 1. THE CUSTOMER VERIFIED QUALITY CONTROL (QC). UPON RESET IN GRAPHIC USER INTERFACE (GUI), THE BIO-WASTE PUMP STOPPED FUNCTIONING. DURING THE FOLLOW-UP VISIT, THE CSE INSTALLED A NEW BIO-PUMP. THE WATER WAS PUMPING PROPERLY. THE CSE THEN REPLACED THE UV LAMPS AND RESET THE TIMER. QUICK CHECK WAS RUN, WHICH PASSED AND QC WAS VERIFIED BY THE CUSTOMER. THE CAUSE OF THE OPERATOR RECEIVING A CUT ON HIS FINGER WAS DUE TO A JAMMED FLEX. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION VISTA 1500 INSTRUMENT WAS REMOVING A JAMMED FLEX FROM THE TRASH CHUTE. THIS IS WHEN THE FLEX BROKE AND THE OPERATOR RECEIVED A CUT ON HIS FINGER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THE OPERATOR WENT TO AN EMERGENCY ROOM AND HAD THE WOUND CLEANED AND EXAMINED AND WAS THEN RELEASED FROM THE EMERGENCY ROOM. THERE ARE NO REPORTS OF IMPACT ON PATIENT TESTING. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE OPERATOR RECEIVING A CUT ON HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508723 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1