BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 14369841 · Received May 12, 2022

    Report

    Report Number
    2515872-2022-00040
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Report Date
    May 26, 2022
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A RETROSPECTIVE COMPLAINT REVIEW, DEVILBISS HEALTHCARE IDENTIFIED A THERMAL RELATED COMPLAINT INVOLVING DEVILBISS MODEL 525DS OXYGEN CONCENTRATOR. THE COMPLAINT WAS REPORTED AS "OUT OF BOX FAILURE, ALARMING" IN AUGUST OF 2018. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE ROOT CAUSE INVESTIGATION REVEALED THERMAL DEFORMATION TO THE REAR COMPRESSOR HOUSING CAUSED BY A BENT FAN GUARD (SHIPPING DAMAGE) THAT PREVENTED THE COOLING FAN FROM SPINNING PROPERLY. THE UNIT LOGGED NUMEROUS HIGH TEMPERATURE ALARMS BUT WAS OTHERWISE RUNNING TO SPECIFICATION. DEVILBISS HAS AN ACTIVE CAPA FOR FAN RELATED ISSUES.

    Description of Event or Problem · 0

    DURING A RETROSPECTIVE COMPLAINT REVIEW, DEVILBISS HEALTHCARE EXAMINED A COMPLAINT RECEIVED FROM A DISTRIBUTOR IN AUGUST, 2018 INVOLVING A DEVILBISS OXYGEN CONCENTRATOR THAT DEMONSTRATED "OUT OF BOX FAILURE, ALARMING." 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 COMPRESSOR HOUSING. THE UNIT LOGGED NUMEROUS HIGH TEMPERATURE ALARMS BUT WAS OTHERWISE RUNNING TO SPECIFICATION, AND THE INTERNAL THERMAL CUT-OFF WOULD HAVE OPERATED TO SHUT THE UNIT DOWN AT THE PROPER CUT-OFF TEMPERATURE. DEVILBISS HAS AN ACTIVE CAPA FOR FAN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132240 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown