BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE MEDICAL

    MDR report key: 15808049 · Received November 16, 2022

    Report

    Report Number
    2438477-2022-00112
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Report Date
    July 12, 2023
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    BTI
    UDI-DI
    00885304002536
    PMA / PMN Number
    K031413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PORTABLE COMPRESSOR NEBULIZER BY A DISTRIBUTOR, WHO STATED THE "UNIT IS SPARKING AT THE TUBING CONNECTOR WHEN POWERING ON." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PORTABLE COMPRESSOR NEBULIZER BY A DISTRIBUTOR, WHO STATED THE "UNIT IS SPARKING AT THE TUBING CONNECTOR WHEN POWERING ON." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832766 DRIVE MEDICAL NEBULIZER COMPRESSOR BTI VEGA TECHNOLOGIES INC. 6910P-DR 00885304002536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown