BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3671893 · Received February 24, 2014

    Report

    Report Number
    1217157-2014-00025
    Event Type
    Other
    Date Received
    February 24, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT A PO2 RESULT OF LESS THAN 42.0 WOULD HAVE BEEN REVIEWED BY THE TECHNICIANS. SHE INDICATED THAT ALL PATIENT RESULTS ARE REVIEWED IN THE MORNING. THE SIEMENS REP CHECKED THE INSTRUMENT AND FOUND THAT THE ANALYTICAL RANGES WERE DISABLED ON THE INSTRUMENT. THE CUSTOMER WAS INSTRUCTED TO RE-ENABLE THE ANALYTICAL RANGES ON THE INSTRUMENT. INSTRUMENT IS PERFORMING AS INTENDED. THIS EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT A PATIENT PO2 RESULT WAS REPORTED TO THE PHYSICIAN THAT WAS BELOW THEIR ANALYTICAL RANGE LIMITS SET ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111660 RAPIDPOINT 405 RP 405 GKR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1