BEUDAMED
    FDA Adverse Event Other Summary report: N

    NE-C21 COMP AIR ELITE NEBULIZER SYSTEM

    MDR report key: 2093668 · Received April 20, 2011

    Report

    Report Number
    1450057-2011-00001
    Event Type
    Other
    Date Received
    April 20, 2011
    Date of Event
    July 23, 2008
    Report Date
    April 20, 2011
    Manufacturer
    RESPIRONICS, NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K914836/B
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS FOUND DURING A LOOK BACK OF DEVICE COMPLAINTS. INITIALLY DETERMINED NOT TO BE A REPORTABLE EVENT BY PREVIOUS QA MANAGEMENT. EVENT CLASSIFIED AS USER ERROR. ON FOLLOW-UP CALL CUST CLAIMS SHE EXPERIENCED AN ALLERGIC REACTION AND ASTHMA ATTACK WHILE NEBULIZING. CLAIMS SHE WAS HOSPITALIZED FOR THREE (3) DAYS. CUSTOMER CONFIRMED SHE IS NOT FOLLOWING THE CLEANING INSTRUCTIONS DETAILED IN THE MANUAL NOR HAS SHE EVER REPLACED THE NEBULIZER KIT EVERY SIX MONTHS AS RECOMMENDED IN THE CLEANING AND MAINTENANCE SECTION OF THE INSTRUCTION MANUAL. THE MANUAL ALSO INDICATES TO CHANGE THE FILTER EVERY 30 DAYS OR WHEN IT TURNS GREY. CUSTOMER CLAIMS SHE FOLLOWED HER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS ON CARE AND MAINTENANCE OF THE UNIT AND NOT THE INSTRUCTION MANUAL. CLAIMS INSTRUCTED BY A TECH AT THE DOCTOR'S OFFICE 'AT THE END OF THE DAY ON HER FINAL USE TO CLEAN THE PARTS WITH AN ANTIBACTERIAL SOLUTION, RINSING ALL THE PARTS WITH THE HOTTEST WATER TEMP SHE COULD STAND ALLOWING PARTS TO AIR DRY.' CLAIMS TECH INSTRUCTED HER ONLY IF UNIT BECOMES CAKED WITH MEDS TO ADDITIONALLY SOAK FOR FIVE MINUTES IN WARM WATER SOLUTION. UNIT WAS RECEIVED IN THE REPAIR CENTER GROSSLY CONTAMINATED WHICH MADE AN EVALUATION IMPOSSIBLE. IT WAS DETERMINED THE UNIT MALFUNCTIONED DUE TO USER'S FAILURE TO FOLLOW CLEANING INSTRUCTIONS AND ROUTINE FILTER REPLACEMENT. THIS UNIT WAS DESTROYED AT THE END OF ROUTINE RETENTION PERIOD IN THE REPAIR CENTER. THIS IS AN INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS EVERY TIME SHE USES HER UNIT BACK EAST, SHE GETS SICK. CLAIMS IT ALMOST BURNED HER MOUTH AND THROAT WHEN SHE INHALED THE UNIT. CLAIMS WHEN SHE INHALES HER MEDICINE, IT PRODUCES A BURNING SENSATION IN HER MOUTH AND DOWN HER THROAT. CLAIMS WHEN SHE INHALES IT FEELS LIKE HER THROAT IS GETTING BLASTED FROM SAND. CLAIMS HER FILTER IS GREEN WITH MOLD EVERY TIME SHE USES THE UNIT BACK EAST. CLAIMS SHE HAD AN ALLERGIC REACTION TO THE MOLD THAT FORMS ON HER FILTER AFTER EVERY BREATHING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NE-C21 COMP AIR ELITE NEBULIZER SYSTEM COMPRESSOR NEBULIZER CAF RESPIRONICS, NEW JERSEY, INC. NE-C21 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization