BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 14787127 · Received June 23, 2022

    Report

    Report Number
    2515872-2022-00034
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING A RETROSPECTIVE COMPLAINT REVIEW, DEVILBISS HEALTHCARE EXAMINED A COMPLAINT RECEIVED FROM A DISTRIBUTOR ON (B)(6) 2018, INVOLVING A DEVILBISS OXYGEN CONCENTRATOR STATING THAT THE UNIT WAS "CONSTANTLY ALARMING." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED FOR EVALUATION AND WAS DETERMINED TO BE OPERATING TO SPECIFICATION, ALTHOUGH THERE WAS SOME EVIDENCE OF THERMAL DEFORMATION TO THE COMPRESSOR HOUSING AND REAR CABINET. THE FINDINGS INDICATE THERE WAS TEMPORARY BLOCKAGE OF THE FAN, PREVENTING ADEQUATE AIRFLOW AND EFFECTIVE COOLING OF THE COMPRESSOR HOUSING. THE UNIT ALARMED AS INTENDED AND THE DEVICE WAS PRODUCING OXYGEN TO SPECIFICATION. THE FAN WAS REPLACED. DEVILBISS HAS AN ACTIVE CAPA FOR FAN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454494 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown