BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMMA CAPNOGRAPH, KPA

    MDR report key: 16443861 · Received February 27, 2023

    Report

    Report Number
    3019388613-2023-00047
    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

    ADDITIONAL MANUFACTURING NARRATIVE: 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION FOUND THE DETECTOR LENS WAS TILTED. THE DEVICE WAS ABLE TO POWER ON AND OFF USING BATTERY POWER AND WAS ABLE TO OBTAIN MEASUREMENTS WITH ALL OF THE ENABLED PARAMETERS. WHEN A CO2 GAS MIXTURE WAS APPLIED, THE MEASURED VALUES WERE OUTSIDE THE ACCURACY SPECIFICATION. AFTER PERFORMING ZEROING OF THE DEVICE, THE MEASURED VALUES REMAINED OUTSIDE OF THE ACCURACY SPECIFICATION DUE TO THE TITLED DETECTOR LENS. 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
    752820 EMMA CAPNOGRAPH, KPA ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK MASIMO - 15750 ALTON PKWY 18266 07350046131040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown