BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16451659 · Received February 28, 2023

    Report

    Report Number
    2438477-2023-00015
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Report Date
    February 27, 2023
    Manufacturer
    SHENZHEN HOMED MEDICAL DEVICE CO LTD
    Product Code
    CAF
    UDI-DI
    00822383269917
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY AN END USER, WHO STATED THAT "THEY WERE USING THE UNIT AND THE COMPRESSOR BECAME HOT AND MELTED THE TUBING JUST PAST WHERE THE TUBING CONNECTS TO THE UNIT." 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
    409451 DRIVE NEBULIZER CAF SHENZHEN HOMED MEDICAL DEVICE CO LTD 18080 00822383269917

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown