BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-LNCS Y-I

    MDR report key: 6790854 · Received August 12, 2017

    Report

    Report Number
    2031172-2017-00788
    Event Type
    Malfunction
    Date Received
    August 12, 2017
    Date of Event
    July 19, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K041815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED., INITIAL REPORTER ZIP CODE EXCEEDED MAXIMUM ALLOWABLE DIGITS, (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSORS WERE EVALUATED. FOR TWO (2) SENSORS THE EEPROM CONTENT VERIFICATION DID NOT IDENTIFY ANY ISSUES. NO PHYSICAL DAMAGE WAS OBSERVED AND THE SENSORS PASSED CONTINUITY TESTING. THE TWO (2) SENSORS WERE FOUND TO BE FUNCTIONING AS DESIGNED. INITIAL REPORTER ZIP CODE (B)(6), OCCUPATION: COMPANY REPRESENTATIVE, DISTRIBUTOR". THE FOLLOWING FIELDS WERE UPDATED TO REFLECT ADDITIONAL INFORMATION REGARDING THIS REPORTED COMPLAINT: FIELD DESCRIPTION WAS UPDATED FROM "THE CUSTOMER REPORTED M-LNCS Y-I SENSORS WHICH INTERMITTENTLY DISPLAY ERROR MESSAGES AND LOW SPO2 AND BPM MEASUREMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED." TO "THE CUSTOMER REPORTED FIFTEEN M-LNCS Y-I SENSORS, SOME OCCUR SENSOR OFF, SOME OCCUR REPLACE SENSOR. SOME OF THE SPO2 AND BPM READINGS ARE VERY LOW, ALL THE ISSUES ARE INTERMITTENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED." LOT # WAS UPDATED FROM "BLANK" TO "K16JXE". MODEL # WAS UPDATED FROM "BLANK" TO "2505-2", EXP. DATE WAS UPDATED FROM "BLANK". TO "09/01/2019" , AND THE UDI # WAS UPDATED FROM "BLANK" TO "(B)(4)". DATE DEVICE RETURNED TO MANUFACTURER WAS UPDATED FROM "BLANK" TO "08/03/2017". 510K # UPDATED FROM "BLANK" TO "K041815". DEVICE MANUFACTURER DATE UPDATED FROM "BLANK" TO "09/28/2016".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED M-LNCS Y-I SENSORS WHICH INTERMITTENTLY DISPLAY ERROR MESSAGES AND LOW SPO2 AND BPM MEASUREMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FIFTEEN M-LNCS Y-I SENSORS, SOME OCCUR SENSOR OFF, SOME OCCUR REPLACE SENSOR. SOME OF THE SPO2 AND BPM READINGS ARE VERY LOW, ALL THE ISSUES ARE INTERMITTENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570984 M-LNCS Y-I OXIMETER DQA MASIMO - 40 PARKER 2505-2 K16JXE

    Patients

    Seq Age Sex Outcome Treatment
    1