BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 4274201 · Received November 24, 2014

    Report

    Report Number
    1217157-2014-00176
    Date Received
    November 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REPRESENTATIVE ASSISTED CUSTOMER TO TURN OFF "SAVE DEMOGRAPHICS" FEATURE WITHIN SETUP AND VERIFIED THAT LAST PATIENT ICON NOT AVAILABLE BY RUNNING TEST SAMPLE. CUSTOMER INDICATED THAT THEY DO NOT HAVE ANY FURTHER QUESTIONS. INSTRUMENT IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY ERRONEOUSLY USED THE LAST PATIENT BUTTON ON INSTRUMENT TO POPULATE THE DEMOGRAPHICS FOR ANOTHER PATIENT'S SAMPLE THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759863 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1