BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AC/DC SUCTION MACHINE

    MDR report key: 23081208 · Received September 18, 2025

    Report

    Report Number
    3003188183-2025-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    June 21, 2021
    Report Date
    September 16, 2025
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    JCX
    PMA / PMN Number
    K102626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NA.

    Description of Event or Problem · 0

    DEFECT DESCRIPTION: ACCORDING TO CONSUMER, THE UNIT CAUGHT ON FIRE; HOWEVER, WAS NOT IN USE AT THE TIME OF THE EVENT. IT WAS PLUGGED IN, PRESUMABLY TO CHARGE THE UNIT. THE SINGLE POWER LINE OF THE MACHINE IDENTIFIED WAS NOT ORIGINAL TO THE MACHINE. CAUSE ANALYSIS: 5.1. AS THE DEFECTIVE PRODUCTS WERE NOT RETURNED AND THE CUSTOMER DID NOT PROVIDE ANY OTHER RELEVANT INFORMATION, IT IS IMPOSSIBLE TO TRACE THEIR PRODUCTION INFORMATION. 5.2. ACCORDING TO THE CUSTOMER'S DESCRIPTION, THE PRODUCT CAUGHT FIRE WHEN THE CONSUMER WAS CHARGING IT WITH AN EXTERNAL ADAPTER (NOT THE ADAPTER THAT CAME WITH THE PRODUCT). 5.3. AS THE CUSTOMER DID NOT PROVIDE ANY INAPPROPRIATE PICTURES, THE BURNED COMPONENTS COULD NOT BE CONFIRMED. VEGA VERIFIED THROUGH SIMULATION THAT IT MIGHT BE THAT THE CONSUMER USED AN MISMATCHED ADAPTER TO CHARGE THE PRODUCT, CAUSING THE INTERNAL GOLD FILM RESISTOR TO BURN OUT, WHICH LED THE CONSUMER TO DETERMINE THAT IT WAS A 5.4. AFTER REVIEWING VEGA'S CHARGING VERIFICATION OF THE PRODUCT WITH DIFFERENT VOLTAGES IN 2024, THE VERIFICATION RESULTS SHOW THAT WHEN THE PRODUCT IS CHARGED AT 13.5V FOR 15 MINUTES, THE TEMPERATURE OF THE GOLD FILM RESISTOR REACHES 79.3 DEGREES. WHEN THE PRODUCT IS CHARGED AT 14.5V FOR 3 MINUTES, THE GOLD FILM RESISTOR BURNS OUT. CHARGE THE PRODUCT WITH 15V VOLTAGE FOR 1 MINUTE, AND THE GOLD FILM RESISTOR BURNS OUT. 5.5. THE VEGA MANUAL CLEARLY STIPULATES THAT WHEN USING THE PRODUCT, ORIGINAL ACCESSORIES MUST BE USED. IN CONCLUSION: THE POSSIBLE CAUSE OF THE PRODUCT BURNING OUT COULD BE: CONSUMERS USED AN INCOMPATIBLE ADAPTER TO CHARGE THE PRODUCT, WHICH LED TO THE BURNING OUT OF THE PRODUCT'S GOLD FILM RESISTOR AND THUS CAUSED THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704745 PORTABLE AC/DC SUCTION MACHINE SUCTION MACHINE, PRODUCT CODE: LRQ JCX VEGA TECHNOLOGIES INC. SU100DC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization