BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP OS/KIT, ADULT MEDIUM CIRCUIT

    MDR report key: 1213588 · Received October 27, 2008

    Report

    Report Number
    MW5008792
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 27, 2008
    Manufacturer
    EMERGENCY RESPIRATORY PRODUCTS
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CPAP BREATHING CIRCUIT MALFUNCTIONED DUE TO A STUCK DIAPHRAGM FOR THE PORTO2 VENT, CAPAP OS. THIS PRECLUDED THE DEVICE FROM BEING USED ON A PATIENT IN SEVERE RESPIRATORY DISTRESS WITH LOW OXYGEN SATURATION -89% ON A NON REBREATHER MASK-. THE FAILURE WAS DETECTED BY THE EMS PROVIDER, AND THE PATIENT WAS RETURNED TO A NON REBREATHER MASK. HER OXYGEN SATURATIONS EVENTUALLY IMPROVED WITH MEDICATIONS AND OXYGEN VIA NRB MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP OS/KIT, ADULT MEDIUM CIRCUIT NONE BYE EMERGENCY RESPIRATORY PRODUCTS ERP1234-2M/06272008

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization CPAP OS