BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS TC-I SENSOR

    MDR report key: 5042118 · Received August 31, 2015

    Report

    Report Number
    2031172-2015-01053
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 31, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR 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 · 1

    PT AGE : (B)(6) YEARS. PT GENDER : MALE. PT WEIGHT: (B)(6). ADVERSE EVENT ALSO SELECTED. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). DATE OF EVENT UPDATED TO (B)(6) 2015. UPDATED TO INCLUDE PATIENT'S CONDITION AFTER THE EVENT. UPDATED MODEL# AND CATALOG# TO 1895. INITIAL REPORTER: UPDATED CONTACT NAME AND OCCUPATION PMA 510(K): UPDATED 510(K) NUMBER TO K051212. LABEL FOR SINGLE USE : UPDATED TO 'NO.' THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. NO PRODUCT PERFORMANCE ISSUES RELATING TO SPO2 WAS OBSERVED. A REVIEW OF THE HISTORY FOR THIS DEVICE WAS PERFORMED AND IT WAS CONCLUDED THAT THE DEVICE WAS IN THE FIELD FOR OVER THREE (3) MONTHS WITH NO PREVIOUS RETURNS OR OTHER ISSUES PRIOR TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "THE PATIENT HAD SATURATIONS ON THE MASIMO EAR CLIP IN THE HIGH 90'S - SPECIFICALLY 94-96%, HOWEVER SHOWED PROGRESSIVE SIGNS OF RESPIRATORY DISTRESS (I.E. TACHYPNEA). THIS EAR PROBE WAS SPORADICALLY MOVED FROM THE R TO L EAR. DUE TO THE RESPIRATORY DISTRESS, AN ABG WAS OBTAINED - THE MASIMO SATS WERE 96%, ABG SPO2 WAS 77.8% AND THE PAO2 WAS 37.8. APPROXIMATELY 20 MINUTES LATE, A REPEAT ABG WAS DONE WITH THE FOLLOWING READINGS: MASIMO SATS WERE 89%, ABG SPO2 WAS 83.3% AND THE PAO2 WAS 43.5. THIS PATIENT REQUIRED REINTUBATION. BOTH ABGS WERE PULLED FROM A L BRACHIAL ARTERIAL LINE."

    Description of Event or Problem · 1

    CUSTOMER REPORTED "THE PATIENT HAD SATURATIONS ON THE MASIMO EAR CLIP IN THE HIGH 90'S - SPECIFICALLY 94-96%, HOWEVER SHOWED PROGRESSIVE SIGNS OF RESPIRATORY DISTRESS (I.E. TACHYPNEA). THIS EAR PROBE WAS SPORADICALLY MOVED FROM THE RIGHT TO LEFT EAR. DUE TO THE RESPIRATORY DISTRESS, AN ABG WAS OBTAINED - THE MASIMO SATS WERE 96%, ABG SPO2 WAS 77.8% AND THE PAO2 WAS 37.8. APPROXIMATELY 20 MINUTES LATE, A REPEAT ABG WAS DONE WITH THE FOLLOWING READINGS: MASIMO SATS WERE 89%, ABG SPO2 WAS 83.3% AND THE PAO2 WAS 43.5. THIS PATIENT REQUIRED REINTUBATION. BOTH ABGS WERE PULLED FROM A LEFT BRACHIAL ARTERIAL LINE." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTED THAT THE PATIENT WAS "CRITICAL BUT GUARDED" AFTER THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575390 LNCS TC-I SENSOR OXIMETER DQA MASIMO CORPORATION 1895 15DAE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PHILIPS X2 MMS WITH MASIMO SET