BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVO MEDICAL'S AEROMAX 3002 NEBULIZER

    MDR report key: 1006462 · Received March 3, 2008

    Report

    Report Number
    1931654-2008-00001
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 3, 2008
    Manufacturer
    EVO MEDICAL SOLUTIONS
    Product Code
    CAF
    PMA / PMN Number
    K942444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RETURNED ON 02/21/08. POWER SWITCH HAD BURNT/MELTED. THE COMPRESSORS WERE CONNECTED TO POWER SOURCE AND THEY OPERATED NORMALLY WITHOUT DRAWING EXCESSIVE CURRENT. ALL ELECTRONICS FUNCTIONED PROPERLY. THERE WAS NO APPARENT ELECTRICAL REASON FOR SWITCH OVERHEATING. NOTE: DEVICES RETURNED DID NOT HAVE THE SWITCH COVERS IN PLACE. THERE WAS NO APPARENT ELECTRICAL REASON FOR SWITCH OVERHEATING. CONCLUSIONS: MALFUNCTION OF DEVICE OCCURRED BECAUSE THE PROTECTIVE COVER ON THE SWITCH HAD BEEN REMOVED. THE LACK OF A SWITCH COVER ALLOWED LIQUID MEDICATION TO ENTER THE SWITCH CAUSING THE SWITCH TO MELT IN THE OFF POSITION. USER REMOVED SAFETY DEVICE.

    Description of Event or Problem · 1

    COMPLAINT FROM CUSTOMER THAT CASE HAD DEFORMED (MELTED) BY POWER SWITCH/FUSE. CUSTOMER E-MAILED A PHOTO THAT APPEARED TO SHOW THE PLASTIC WAS HOT, POSSIBLY MELTED. THE PT WAS NOT USING THE DEVICE AT TIME OF MALFUNCTION. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVO MEDICAL'S AEROMAX 3002 NEBULIZER AEROMAX 3002 NEBULIZER COMPRESSOR CAF EVO MEDICAL SOLUTIONS 3002-230CE-UK-1

    Patients

    Seq Age Sex Outcome Treatment
    1