BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 3763292 · Received April 22, 2014

    Report

    Report Number
    1217157-2014-00062
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT PCO2 RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT PCO2 RESULTS ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242383 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1