BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVO MEDICAL'S AEROMAX 3002 NEBULIZER

    MDR report key: 1250876 · Received December 1, 2008

    Report

    Report Number
    1931654-2008-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 13, 2008
    Report Date
    December 1, 2008
    Manufacturer
    EVO MEDICAL SOLUTIONS
    Product Code
    CAF
    PMA / PMN Number
    K942444
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED ON 11/25/2008. POWER SWITCH HAD MELTED/BURNT. THE COMPRESSOR WAS CONNECTED TO POWER SOURCE AND IT OPERATED NORMALLY WITHOUT DRAWING EXCESSIVE CURRENT. ALL ELECTRONICS FUNCTIONED PROPERLY. THERE WAS NO APPARENT ELECTRICAL REASON FOR SWITCH OVERHEATING. THE DEVICE HAS SIGNS OF A LIQUID (MEDICATION OR OTHER) INSIDE THE CASE. INITIAL CONCLUSIONS: MALFUNCTION OF DEVICE OCCURRED BECAUSE LIQUID WAS ALLOWED TO ENTER CASE. THE LIQUID MEDICATION OR OTHER LIQUID ENTERED THE SWITCH FROM INSIDE THE CASE CAUSING THE SWITCH TO FAIL. USER DID NOT FOLLOW INSTRUCTIONS IN MANUAL. EVALUATION STARTED.

    Description of Event or Problem · 1

    COMPLAINT FROM CUSTOMER THAT SWITCH HAD MELTED. CUSTOMER E-MAILED A PHOTO THAT APPEARED TO SHOW THE PLASTIC AROUND THE SWITCH WAS DEFORMED PARTIALLY MELTED. THE PT WAS USING THE DEVICE AT THE TIME. 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