BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIRDIE BEDSIDE SPO2 MONITOR, 2 PINS, BLUE

    MDR report key: 6305268 · Received February 6, 2017

    Report

    Report Number
    2936999-2017-00088
    Event Type
    Death
    Date Received
    February 6, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 10, 2017
    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).

    Description of Event or Problem · 1

    COVIDIEN/MEDTRONIC RECEIVED A REPORT THE PATIENT PASSED AWAY ON HOME-CARE. PATIENT WAS USING A VENTILATOR FROM (B)(4). AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION OR IF THE BEDSIDE MONITOR HAD CONTRIBUTED TO THE PATIENT EVENT. COVIDIEN IS REQUESTING ADDITIONAL INFORMATION INCLUDING DATE OF PATIENT DEATH, FAILURE AND PATIENT IDENTIFIER INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE INFORMATION WILL PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87357 BIRDIE BEDSIDE SPO2 MONITOR, 2 PINS, BLUE PULSE OXIMETRY DQA MEDIANA 10005941JPN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death