BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O3 REGIONAL OXIMETER MODULE

    MDR report key: 8453407 · Received March 26, 2019

    Report

    Report Number
    2031172-2019-00148
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 6, 2019
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MUD
    UDI-DI
    00843997010771
    PMA / PMN Number
    K160526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. EXTERNAL VISUAL INSPECTION SHOWED NO DAMAGE. THE MODULE WAS PLACED IN THE TEST FIXTURE AND MEASUREMENTS WERE OBTAINABLE ON CHANNEL 2 ONLY. THE OBTAINED MEASUREMENTS WERE CONTINUOUS WITH CABLE AND CONNECTOR MANIPULATION AND THE RECORDED VALUES WERE CONSISTENT WITH A KNOWN GOOD MODULE. INTERNAL INSPECTION SHOWED CONTAMINANT ON THE FEMALE MATING PIN OF THE MODULE. THE CUSTOMER COMPLAINT WAS NOT DUPLICATED HOWEVER THE PRESENCE OF THE CONTAMINANT IS A POSSIBLE ROOT CAUSE OF THE REPORTED COMPLAINT. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER FIVE (5) MONTHS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ACCURACY ISSUES WITH THE DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED. PER THE REPORTED ISSUE, DURING OPENING OF THE STERNUM THERE WAS NO VALUE MEASUREMENT OF O3 FOR 1 MINUTE. AFTER THAT THE R 37% AND L 17% DELTA OF 20% BETWEEN L AND R. DELTA REMAINS THE SAME FOR 15 MINUTES THAN DECREASES TO 10% FOR 10 MINS. AFTER THAT GRADUALLY INCREASING OF DELTA AGAIN WHERE L GOES DOWN TO 0% AND RIGHT TO 30%. DURING PROCEDURE THE VALUES REMAIN LOW R 40% AND L 20-30%. MEDICAL MANAGEMENT WAS ADJUSTED ACCORDINGLY TO O3 VALUES, MORE INOTROPES WERE GIVEN. TEMP DURING SURGERY 35-36 DEGREES CELSIUS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ACCURACY ISSUES WITH THE DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED. PER THE REPORTED ISSUE, DURING OPENING OF THE STERNUM THERE WAS NO VALUE MEASUREMENT OF O3 FOR 1 MINUTE. AFTER THAT THE R 37% AND L 17% DELTA OF 20% BETWEEN L AND R. DELTA REMAINS THE SAME FOR 15 MINUTES THAN DECREASES TO 10% FOR 10 MINS. AFTER THAT GRADUALLY INCREASING OF DELTA AGAIN WHERE L GOES DOWN TO 0% AND RIGHT TO 30%. DURING PROCEDURE THE VALUES REMAIN LOW R 40% AND L 20-30%. MEDICAL MANAGEMENT WAS ADJUSTED ACCORDINGLY TO O3 VALUES, MORE INOTROPES WERE GIVEN. TEMP DURING SURGERY 35-36 DEGREES CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246624 O3 REGIONAL OXIMETER MODULE OXIMETER MUD MASIMO - 40 PARKER 24667 00843997010771

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR