BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 405

    MDR report key: 4122768 · Received September 26, 2014

    Report

    Report Number
    1217157-2014-00143
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) LEVEL 2 AND LEVEL 3 RESULTS FOR PO2 OUT OF RANGE. CUSTOMER INDICATED THAT THEIR PROBLEM WAS RESOLVED WITH USING NEW AQC CARTRIDGE AND SYSTEM IS OPERATIONAL AT THIS TIME. CUSTOMER ALSO INDICATED THAT THEY HAVE NO FURTHER QUESTIONS AT THIS TIME AND WILL CALL BACK IF FURTHER ASSISTANCE IS REQUIRED OF TECHNICAL SUPPORT. INSTRUMENT IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AUTOMATIC QUALITY CONTROL (AQC) LEVEL 2 AND LEVEL 3 RESULTS FOR PO2 WERE OUT OF RANGE ON INSTRUMENT. CUSTOMER REPORTED THAT PATIENT SAMPLES WERE RUN WHEN AQC LEVEL 2 AND LEVEL 3 RESULTS FOR PO2 OUT OF RANGE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601669 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1