BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 4792533 · Received May 22, 2015

    Report

    Report Number
    1217157-2015-00064
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SHOULD NOT HAVE RESTORED FAILED AQC PARAMETER (PO2) AND RUN PATIENT SAMPLES. CUSTOMER WOULD LIKE TO KNOW WHICH OPERATOR RESTORED THE PCO2 PARAMETER. CUSTOMER HAS BEEN REQUESTED TO PROVIDE PAZ FILE (IN SOME CASES DEPENDING ON SEQUENCE AND NUMBER OF REBOOTS THIS INFORMATION CAN BE FOUND IN THE PAZ FILE). HOWEVER, THE ANSWER FOR CUSTOMER'S QUESTION COULD NOT BE GUARANTEED BECAUSE THE RP405 DOES NOT HAVE LOGGING CAPABILITY TO DETERMINE WHO RESTORED AQC AND SYSTEM WAS NOT DESIGNED FOR THIS FUNCTIONALITY. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR. SYSTEM IS OPERATIONAL AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER RESTORED FAILED AUTOMATIC QUALITY CONTROL (AQC) PARAMETER (PCO2) AND RUN 10 PATIENT SAMPLES ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334773 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1