BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 405

    MDR report key: 3893566 · Received June 25, 2014

    Report

    Report Number
    1217157-2014-00088
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Removal / Correction Number
    1217157-08-21-2013-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE URGENT FIELD SAFETY NOTICE #30652 WAS HANDED TO THE CUSTOMER ON 11/22/2013 WITH EXPLANATION OF THE ISSUE. THE EVENT HAS OCCURED DUE TO 'PATIENT LIST BUTTON' WAS ENABLED ON THE INSTRUMENT. AN UPGRADED SOFTWARE V3.9 HAS AN ENHANCEMENT TO THE"PATIENT LIST" FEATURE. IN THIS IMPROVISED SOFTWARE, WHEN THE PATIENT LIST FEATURE IS USED TO ENTER PATIENT DEMOGRAPHIC DATA, THE SYSTEM NO LONGER PRESELECTS THE FIRST RECORD IN THE PATIENT LIST AND THIS MINIMIZES THE CHANCES OF SELECTING THE INCORRECT PATIENT. CUSTOMER INDICATED THAT RESULT ON INCORRECT PATIENT ID WAS NOT REPORTED. CUSTOMER ALSO INDICATED THAT THEY UPGRADED THE SYSTEM WITH SOFTWARE(V3.9).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INCORRECT PATIENT ID WAS ATTACHED TO THE RESULTS WHEN IT PRINTED OUT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370412 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1