BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISA CO2

    MDR report key: 16078143 · Received December 30, 2022

    Report

    Report Number
    3019388613-2022-00278
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 7, 2022
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    PMA / PMN Number
    K171121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. DURING SIMULATION TESTING, THE DEVICE PASSED MANUAL AND PRESET CONDITIONS AND PROVIDED ACCURATE MEASUREMENTS. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED., CORRECTED DATA: D1: WAS REPORTED AS EMMA, THE ACTUAL IS ISA CO2. D2: WAS REPORTED AS CCK, ACTUAL IS MWI; COMMON DEVICE NAME WAS REPORTED AS OXIMETER, ACTUAL IS MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS). D4: MODEL NUMBER WAS REPORTED AS 18265, THE ACTUAL IS 800101, CATALOG NUMBER WAS REPORTED AS 3639, THE ACTUAL IS 4410; UDI WAS REPORTED AS (B)(4), ACTUAL IS (B)(4). G5: WAS REPORTED AS K063167, ACTUAL IS K171121.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE DOES NOT REGISTER ACCURATE NUMBERS FOR CO2 LEVELS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE DOES NOT REGISTER ACCURATE NUMBERS FOR CO2 LEVELS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202856 ISA CO2 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 800101
    2767712 ISA CO2 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 800101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown