BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAMED JOJO THE JELLYFISH PEDIATRIC COMPRESSOR NEBULIZER

    MDR report key: 5368071 · Received January 14, 2016

    Report

    Report Number
    1423537-2016-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 16, 2015
    Report Date
    January 14, 2016
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE SERIAL NUMBER REPORTED WAS REVIEWED AND DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. MULTIPLE ATTEMPTS TO RETRIEVE THE SAMPLE TO AID IN DETERMINING A ROOT CAUSE WERE UNSUCCESSFUL. AS A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONFIRMED. A REVIEW OF THE HISTORICAL TRENDING FOR THE PAST 12 MONTHS INDICATED THAT THIS IS THE FIRST REPORT RECEIVED OF THIS ISSUE. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN FOR HER SON THAT USES THE PEDIATRIC NEBULIZER. WHEN USING THE UNIT AT SCHOOL SPARKS BEGAN TO FLY AND CAUSED THE ELECTRICITY AT THE SCHOOL TO GO OUT. NO ONE WAS INJURED. CUSTOMER HAS HAD THE UNIT ABOUT 1.5 TO 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25432 RELIAMED JOJO THE JELLYFISH PEDIATRIC COMPRESSOR NEBULIZER RELIAMED JOJO THE JELLYFISH PEDIATRIC COMPRESSOR NEBULIZER BTI VEGA TECHNOLOGIES INC. ZRCN02PED 0111

    Patients

    Seq Age Sex Outcome Treatment
    1