BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS HEALTHCARE

    MDR report key: 19818547 · Received July 24, 2024

    Report

    Report Number
    2515872-2024-00039
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 28, 2024
    Report Date
    December 30, 2024
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304022466
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY SUBMITTED REPORT HAD LACKING OR INCORRECT INFORMATION IN SECTION D4 UDI. SECTION D4 HAS BEEN UPDATED WITH THE CORRECT INFORMATION. THE DEVICE MANUFACTURER DATE IN SECTION H4 WAS INCORRECTLY SUBMITTED IN THE PREVIOUS REPORT. H4 HAS BEEN UPDATED WITH THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A PROVIDER WHO REPORTED THE DEVICE HAD MELTED PLASTIC ON THE INSIDE DUE TO OVERHEATING. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE HAS REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371688 DEVILBISS HEALTHCARE GENERATOR, OXYGEN, PORTABLE CAW DEVILBISS HEALTHCARE LLC 1025DS 00885304022466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown