BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 13235972 · Received January 11, 2022

    Report

    Report Number
    MW5106577
    Event Type
    Death
    Date Received
    January 11, 2022
    Date of Event
    October 4, 2021
    Report Date
    January 7, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HIGH FLOW O2 MALFUNCTION, NO O2 DELIVERY; SATS 21%. PLACED ON NONREBREATHER WITH SATS TO 60S THEN ON BIPAP WITH SATS IN 90S. WE CHECKED THIS HFNC DEVICE AND IT APPEARED TO BE FUNCTIONING PROPERLY. NURSES REPORTED NO ALARMS OR MESSAGES; HOWEVER, WHEN IT WAS TAKEN APART FOR CLEANING, A SMALL DEFECT WAS FOUND AT THE GAS OUTLET. BIOMED ALSO CHECKED AND STATED THAT IT APPEARED THE UNIT HAD BEEN DROPPED OR SOMETHING DROPPED ON IT. IT WAS TAKEN OUT OF SERVICE. PT INTUBATED AND EXPIRED 10 DAYS LATER DUE TO COVID. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405051 AIRVO2 HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT FISHER & PAYKEL HEALTHCARE, LTD. PT101US 2101366099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death| R