BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3581672 · Received January 6, 2014

    Report

    Report Number
    1217157-2013-00243
    Event Type
    Other
    Date Received
    January 6, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WRONG PT ID IS BEING SCANNED ON THE INSTRUMENT. CUSTOMER INDICATED THAT THEY CHANGED ALL THE PT DEMOGRAPHICS DATA CORRECTLY EXCEPT PT PRENAME. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8270 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1