BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMMA CAPNOGRAPH, KPA

    MDR report key: 16445706 · Received February 27, 2023

    Report

    Report Number
    3019388613-2023-00046
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 1, 2023
    Report Date
    February 3, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    CCK
    UDI-DI
    07350046131040
    PMA / PMN Number
    K063167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. THE EMMA MEASURED OUTSIDE OF THE SPECIFICATION RANGE FOR CO2 MEASUREMENTS BECAUSE IT WAS NOT ZEROED OUT AS PART OF THE PREVENTATIVE MAINTENANCE. ONCE THE ZEROING PROCEDURE WAS COMPLETED, THE MEASURED VALUE WAS WITHIN THE SPECIFIED RANGE. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE SHOWING LOW READING ON 5% CO2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE SHOWING LOW READING ON 5% CO2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787348 EMMA CAPNOGRAPH, KPA ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK MASIMO - 15750 ALTON PKWY 18266 07350046131040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown