BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 6197462 · Received December 21, 2016

    Report

    Report Number
    2936999-2016-01087
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER: (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) HAS BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. MEDTRONIC IS ATTEMPTING TO GATHER ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES ASSOCIATED TO THIS EVENT. ADDITIONALLY, A REQUEST FOR THE DEVICE MANUFACTURING DATE HAS BEEN SENT TO THE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT HIGH SPO2 READINGS WERE DISPLAYED ON A BIRDIE BEDSIDE SPO2 MONITOR WHILE THE PATIENT WAS IN CARDIAC ARREST. INFORMATION REGARDING ANY REQUIRED INTERVENTION PERFORMED WAS NOT REPORTED. THE CUSTOMER REPORTED THE PATIENT DIED ON (B)(6) 2016, THE CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845669 NELLCOR BIRDIE BEDSIDE SPO2 MONITOR, 3 PINS, WHITE DQA MEDIANA 10005941JP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death