BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 14786844 · Received June 23, 2022

    Report

    Report Number
    2515872-2022-00048
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Report Date
    May 10, 2022
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING A RETROSPECTIVE COMPLAINT REVIEW, DEVILBISS HEALTHCARE IDENTIFIED A COMPLAINT FOR AN OXYGEN CONCENTRATOR. THE EVENT WAS REPORTED AS "FLOW METER DOES NOT WORK". THERE WAS NO INJURY REPORTED. DEVILBISS HEALTHCARE EVALUATED THE UNIT AND DETERMINED THAT THE "FLOW METER WAS BROKEN AND THAT THE BOARD WAS BAD, POTENTIALLY CAUSING THE UNIT NOT TO ALARM." THE FLOW METER AND BOARD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691846 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown