BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUBBLE HUMIDIFIER 7600-0

    MDR report key: 10361791 · Received August 3, 2020

    Report

    Report Number
    MW5095870
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    August 1, 2020
    Report Date
    August 2, 2020
    Product Code
    BTT
    UDI-DI
    00607411700040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD O2 BELOW 50%. OXYGEN SUDDENLY STOPPED FLOWING FROM OUTPUT OF SALTER LABS BUBBLE HUMIDIFIER 7600-0 WITH NO INDICATION OF FAILURE. 3 OUT OF 3 FAILED AFTER JUST A FEW HOURS USE. TEST SHOWED LEAK AT PRESSURE RELIEF VALVE. TESTED RELIEF VALVE PER INSTRUCTIONS AND IT ACTIVATED AND RESET, BUT STILL LEAKED. FIRST FAILURE WAS NOTICED WHEN PATIENTS LIPS TURNED BLUE. REPLACED WITH 2ND UNIT AND FLOW RESUMED UNTIL IT SUDDENLY STOPPED WITH NO INDICATION. LIKEWISE WITH 3RD UNIT. LOT NUMBER (10) 062419. THIS IS A SERIOUS PROBLEM THAT COULD CAUSE DEATH. SEE PRODUCT RECALL FROM 2012 FOR SAME PROBLEM. RECALL NUMBER: Z-0803-2012 RECALL EVENT ID 60270. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824608 BUBBLE HUMIDIFIER 7600-0 HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT 7600-0 (10) 062419 00607411700040
    824609 BUBBLE HUMIDIFIER 7600-0 HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT 7600-0 (10) 062419
    824610 BUBBLE HUMIDIFIER 7600-0 HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT 7600-0 (10) 062419

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other