BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHN BUNN NEB-U-LITE EV

    MDR report key: 4528187 · Received February 4, 2015

    Report

    Report Number
    2428983-2014-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    May 7, 2014
    Report Date
    February 4, 2015
    Manufacturer
    ZONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER SUBMITTED THE RESULTS OF THEIR INVESTIGATION OF THE ACTUAL RETURNED UNIT IN ADDITION TO THE RESULTS OF AN EXEMPLAR UNIT USED TO DUPLICATE THE FAILURE. CONCLUSION: FAILURE DUE TO INCORRECT POWER SUPPLY/VOLTAGE. THE MANUFACTURER RETURNED THE ABOVE TESTED UNITS TO GF HEALTH PRODUCTS, INC. (GFHP). ON 01/09/2015 GFHP DELIVERED BOTH UNITS TO APPLIED TECHNICAL SERVICES, INC. (THIRD PARTY DOMESTIC TESTING LAB) FOR VALIDATION AND FURTHER ANALYSIS. ATS TEST REPORT CONCLUSION: FAILURE OF CUSTOMER DAMAGED UNIT WAS MOST LIKELY DUE TO OPERATING VOLTAGE BEING TOO HIGH, WHICH CAUSED A BREAKDOWN THROUGH THE VARNISH OF THE WINDINGS. THE DAMAGED MOTOR WAS NOT DUE TO A MANUFACTURING DEFECT. ROOT CAUSE OF FAILURE: END USER/CUSTOMER MISUSE. THE UNIT WAS PLUGGED INTO A 220 POWER VOLTAGE. THE LABEL ON THE UNIT AND THE USER MANUAL SPECIFIES 120V. CONCLUSIONS: DAMAGE TO THE MOTOR, INCLUDING BURN MARKS ON WINDINGS AND WARPING OF WINDING HOUSING TO BOTH UNITS WERE ALMOST IDENTICAL. MULTIPLE BURN MARKS ON CUSTOMER DAMAGED MOTOR INDICATE FAILURE WAS NOT CAUSED BY A SINGLE-POINT BREAKDOWN IN THE VARNISH DUE TO MANUFACTURER DEFECT. THERMAL PROTECTION SWITCH IN BOTH UNITS WAS STILL INTACT. MOTORS DID NOT GET HOT ENOUGH FOR VARNISH TO FAIL SIMPLY DUE TO OVERHEATING. FAILURE OF CUSTOMER DAMAGED UNIT WAS MOST LIKELY DUE TO OPERATING VOLTAGE BEING TOO HIGH, WHICH CAUSED A BREAKDOWN THROUGH THE VARNISH OF THE WINDINGS.

    Description of Event or Problem · 1

    DETAILED IN 30-DAY INITIAL REPORT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83495 JOHN BUNN NEB-U-LITE EV NEBULIZER COMPRESSER CAF ZONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. JB0112-061

    Patients

    Seq Age Sex Outcome Treatment
    1