BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B&F DISPOSABLE NON-REBREATHER OXYGEN MASK

    MDR report key: 271554 · Received March 28, 2000

    Report

    Report Number
    1924066-2000-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2000
    Date of Event
    December 26, 1999
    Report Date
    March 27, 2000
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    KGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLIED HEALTHCARE PRODUCTS, INC REC'D PHONE CALL FROM RPTR EMERGENCY MEDICAL DIVISION. THE PHONE CALL WAS TAKEN BY ALLIED'S CUSTOMER SVC REP. RPTR INDICATED THAT RPTR WAS REPORTING AN EVENT THAT HAD OCCURRED ON 12/26/99. RPTR STATED THAT "ON 12/26/1999 AT 06441 HRS, RESPONDED TO AN AIDED CASE AT THE USER FACILITY WHERE THE VICTIM WAS HAVING LABORED BREATHING. HCP PLACED A NON-REBREATHER OXYGEN MASK ON HERE TO DELIVER HIGH FLOW OXYGEN. THE VICTIM WAS STARTING TO GO UNCONSCIOUS AT THIS POINT. HCP THEN NOTICED PT SUCK THE ONE-WAY VALVE FROM INSIDE THE MASK, INTO THEIR THROAT. HCP IMMEDIATELY DETERMINED PT WAS NOT BREATHING, AND AFTER USING AIRWAY OBSTRUCTION TECHNIQUES REMOVED SAME WITH A FINGER SWEEP. VICTIM REGAINED SOME BREATHING THEN WENT INTO CARDIAC ARREST. HCP AND A FELLOW OFFICER PERFORMED CPR, KNOWING THE AMBULANCE WAS ENROUTE. THE REGAINED A PULSE, BUT HAD TO CONTINUE RESCUE BREATHING. THE VICTIM WAS THEN TURNED OVER TO THE AMBULANCE FOR TRANSPORT TO USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B&F DISPOSABLE NON-REBREATHER OXYGEN MASK DISPOSABLE NON-REBREATHER OXYGEN MASK KGB ALLIED HEALTHCARE PRODUCTS, INC. 64059 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening