BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHUCO

    MDR report key: 6742198 · Received July 25, 2017

    Report

    Report Number
    1924066-2017-00002
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 23, 2017
    Report Date
    July 25, 2017
    Manufacturer
    EMG TECHNOLOGY CO. LTD.
    Product Code
    CAF
    PMA / PMN Number
    K043238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION AS RETURNED: NO MARKS ON UNIT INDICATING BURNING OR OVERHEATING. SERIAL NUMBER ON RETURNED UNIT HAS BEEN REMOVED FROM LABEL. THE UNIT WHEN RETURNED FOR EVALUATION HAD THE RUBBER FEET, FILTER, TUBING, INSTRUCTIONS, AND NEBULIZER CUP MISSING. LABEL AND MANUAL: LABEL ON UNIT AND INSTRUCTIONS STATE: OPERATION 20 MINUTES - OFF FOR 40 MINUTES. INSTRUCTIONS STATE: PLACE COMPRESSOR ON A CLEAN, DUST FREE, STABLE AND FLAT SURFACE. WE RESEARCHED INFORMATION ON SKIN BURNS AND IT INDICATED BURNS CAN TAKE PLACE WHEN SURFACE TEMPERATURE EXCEEDS 109 DEGREES FAHRENHEIT. WE RAN THE UNIT FOR SIX (6) HOURS THE HIGHEST TEMPERATURE RECORDED WAS 102.5 DEGREES FAHRENHEIT. TEST RESULTS ARE ON NEXT PAGE. (B)(4) STANDARD LIST SKIN CONTACT TEMPERATURE SHOULD BE BELOW 109 DEGREES FAHRENHEIT. THE TEMPERATURE TEST PERFORMED ON THE RETURNED UNIT INDICATES THIS UNIT SHOULD NOT HAVE BURNED THE PATIENT. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES: ROOM TEMPERATURE 72.5 DEGREES F. ALL READINGS IN DEGREES FAHRENHEIT. TEST (B)(6) 2017. TIME; TOP; FRONT; RIGHT SIDE; LEFT SIDE; BACK; BOTTOM. 20 MINUTES; 98.0; 85.0; 98.0; 77.0; 94.0; 94.0. 1 HOUR; 99.5; 95.0; 93.5; 84.5; 97.5; 98.5. 2 HOURS; 101.0; 94.5; 93.5; 88.0; 85.5; 102.5. 3 HOURS; 99.0; 95.0; 93.5; 90.0; 97.5; 100.5. 6 HOURS; 97.5; 93.5; 93.5; 89.0; 98.5; 98.5.

    Description of Event or Problem · 1

    REPORT STATES THE PATIENT WAS BURNED FROM THE NEBULIZER. FURTHER STATED THAT SHE HAD TWO BLISTERS, ONE ON HER LEFT ARM, AND ONE ON HER LEFT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519861 SCHUCO NEBULIZER CAF EMG TECHNOLOGY CO. LTD. S5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other