BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET YI

    MDR report key: 11584731 · Received March 29, 2021

    Report

    Report Number
    3011353843-2021-00073
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 2, 2021
    Manufacturer
    MASIMO - 52 DISCOVERY
    Product Code
    DQA
    UDI-DI
    00843997013079
    PMA / PMN Number
    K180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED SENSOR WAS EVALUATED. THE DEVICE PASSED VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. THE SENSOR FAILED CONTINUITY TESTS, DUE TO AN OPEN IN THE CABLE ON THE DETECTOR CIRCUIT AT THE BEND RELIEF AREA OF THE SENSOR END. THE SENSOR WAS MALFUNCTIONING AND PROVIDED A "SENSOR OFF PATIENT" ERROR MESSAGE. CORRECTED DATA: D2: COMMON DEVICE NAME CORRECTED FROM "OXIMETER, PRODUCT CODE: DPZ" TO "OXIMETER, PRODUCT CODE: DQA". G5: PMA/510(K) CORRECTED FROM "K080238" TO "K180046".

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED SENSOR WAS EVALUATED. THE DEVICE PASSED VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. THE SENSOR FAILED CONTINUITY TESTS, DUE TO AN OPEN IN THE CABLE ON THE DETECTOR CIRCUIT AT THE BEND RELIEF AREA OF THE SENSOR END. THE SENSOR WAS MALFUNCTIONING AND PROVIDED A "SENSOR OFF PATIENT" ERROR MESSAGE. CORRECTED DATA: D2: COMMON DEVICE NAME CORRECTED FROM "OXIMETER, PRODUCT CODE: DPZ" TO "OXIMETER, PRODUCT CODE: DQA". G5: PMA/510(K) CORRECTED FROM "K080238" TO "K180046".

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SENSOR HAD INTERMITTENT PROBLEMS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SENSOR HAD INTERMITTENT PROBLEMS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SENSOR HAD INTERMITTENT PROBLEMS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482538 RD SET YI OXIMETER DQA MASIMO - 52 DISCOVERY 4054 19K2U 00843997013079

    Patients

    Seq Age Sex Outcome Treatment
    1