BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 13083200 · Received December 24, 2021

    Report

    Report Number
    2515872-2021-00029
    Event Type
    Malfunction
    Date Received
    December 24, 2021
    Report Date
    December 22, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    (B)(6) HEALTHCARE WAS CONTACTED BY A PATIENT REGARDING A 525DS OXYGEN CONCENTRATOR, WHICH THE PATIENT STATED WAS PURCHASED FOR HER BY HER DAUGHTER. THE PATIENT STATED SHE WAS USING THE DEVICE WHEN THE RED (SERVICE REQUIRED) LIGHT ILLUMINATED. SHE ALSO COMMENTED THE DEVICE "SMELLED HOT." WHILE TALKING WITH HER ON THE PHONE, THE PATIENT ADJUSTED THE OXYGEN FLOW METER FROM THE SETTING OF 2 TO 3 LITERS/MIN. THE PATIENT STATED THAT ONCE SHE ADJUSTED THE OXYGEN FLOWMETER TO 3 LITERS/MIN, THE YELLOW (LOW OXYGEN) LIGHT CAME ON, FOLLOWED BY THE GREEN LIGHT (NORMAL OPERATION AND OXYGEN PURITY). THE PATIENT ALSO NOTED THE DEVICE STOPPED "SMELLING." THE PATIENT DID NOT VOICE ANY COMPLAINTS OF ILLNESS OR INJURY AND DID NOT SEEK MEDICAL ATTENTION. WE HAVE REQUESTED THE DEVICE BE RETURNED TO DEVILBISS FOR EVALUATION. DEVILBISS WILL FILE AND FOLLOW-UP ONE THE UNIT IS RETURNED AND EVALUATED AND/OR IF WE RECEIVE ANY NEW OR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982984 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Female