BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIRDIE BEDSIDE SPO2 MONITOR, 3 PINS, WHITE

    MDR report key: 6239615 · Received January 10, 2017

    Report

    Report Number
    2936999-2017-00033
    Event Type
    Death
    Date Received
    January 10, 2017
    Date of Event
    December 14, 2016
    Report Date
    December 15, 2016
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT EXPIRED WHILE BEING MONITORED ON THE SPO2BEDSIDE MONITOR. CUSTOMER DID NOT ALLEGE A PRODUCT MALFUNCTION, HOWEVER A FAILURE INVESTIGATION HAS BEEN REQUESTED ON THE MONITOR. THE CUSTOMER REPORTED THE PATIENT DIED ON (B)(6) 2016 FROM CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21298 BIRDIE BEDSIDE SPO2 MONITOR, 3 PINS, WHITE PULSE OXIMETER DQA MEDIANA 10005941JP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death