BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR50 CONSERVING OXYGEN REGULATOR

    MDR report key: 222941 · Received May 7, 1999

    Report

    Report Number
    1825511-1999-00007
    Event Type
    Malfunction
    Date Received
    May 7, 1999
    Date of Event
    April 6, 1999
    Report Date
    May 7, 1999
    Manufacturer
    PURITAN BENNETT CRYOGENIC EQUIPMENT DIVISION
    Product Code
    CAN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE HOMECARE PROVIDER (HCP) REPORTED THE FOLLOWING INFO: (1) THE PT WAS USING A CR50 AT HIS WORK WHEN A NO FLOW SITUATION OCCURRED. (2) THE PT STARTED TO BLACKOUT. (3) 911 WAS CALLED. (4) BEFORE THE AMBULANCE ARRIVED AT THE SCENE, THE PT BLEW INTO THE CANNULA AND THE CR50 REGAINED OXYGEN FLOW. (5) THE PT WAS NOT TAKEN TO THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CR50 CONSERVING OXYGEN REGULATOR REGULATOR CAN PURITAN BENNETT CRYOGENIC EQUIPMENT DIVISION CR50 813

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR