BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 14786649 · Received June 23, 2022

    Report

    Report Number
    2515872-2022-00033
    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
    OK, 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 IN JULY, 2018 INVOLVING A DEVILBISS OXYGEN CONCENTRATOR THAT DEMONSTRATED A "LOUD BUZZING NOISE, RED WARNING ALARM, VERY HOT." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS EVALUATED THE UNIT AT THE TIME AND DETERMINED THAT A BENT FAN GUARD PREVENTED THE COOLING FAN FROM SPINNING PROPERLY, RESULTING IN THERMAL DEFORMATION TO THE REAR CABINET AND COMPRESSOR HOUSING. DEVILBISS HAS AN ACTIVE CAPA FOR FAN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691820 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown