BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS POSITIVE AIRWAY PRESSURE

    MDR report key: 866858 · Received June 14, 2007

    Report

    Report Number
    MW5002675
    Event Type
    Malfunction
    Date Received
    June 14, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 14, 2007
    Manufacturer
    EMERGENT RESPIRATORY PRODUCTS, INC
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CALL WENT OUT FOR TROUBLE BREATHING. PER PARAMEDIC, HE HAD DIFFICULTY WITH SETTING THE CPAP ADJUSTMENT KNOB. HE STATED WHILE MOVING THE DIAL TO INCREASE THE CM/H2O, IT JUMPED INTO THE #20CM/H2O RANGE WHICH CAUSED THE PATIENT TO HAVE AN EVEN MORE DIFFICULT TIME WITH BREATHING, AFTER SOME TIME HE WAS ABLE TO SET IT TO A MORE COMFORTABLE LEVEL FOR THE PATIENT WHICH HE STATED WAS AROUND 10CM/H2O. PROBLEM: THE KNOB ADJUSTMENT DID NOT WORK SMOOTHLY. DATES OF USE: ONE DAY IN 2007 (20 MINUTES). DIAGNOSIS: CHF. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP NHJ EMERGENT RESPIRATORY PRODUCTS, INC 1900-001

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR