BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 11208523 · Received January 21, 2021

    Report

    Report Number
    2515872-2021-00002
    Event Type
    Death
    Date Received
    January 21, 2021
    Date of Event
    January 4, 2021
    Report Date
    January 21, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE. WHICH IS A OXYGEN CONCENTRATOR. EVALUATION OF THE PRODUCT WILL OCCUR AT THE SERVICE PROVIDERS ESTABLISHMENT. THERE IS LIMITED DATA, DUE TO HIPPA RESTRICTIONS. SERVICE PROVIDER REPORTED, THE CONSUMER BROKE THE XMAS TREE CONNECTOR ON THE DEVICE, WHICH CAUSED IT TO BE INOPERABLE. HE WAS PROVIDED AN ALTERNATIVE OXYGEN SOURCE. AND SERVICE PROVIDER TECHNICIAN WAS DISPATCHED. UPON ARRIVAL OF THE SERVICE PROVIDER'S TECHNICIAN AN AMBULANCE WAS ON SCENE. AND PATIENT HAD EXPIRED. SERVICE PROVIDER TECHNICIAN REPORTED, ALTERNATIVE OXYGEN SOURCE WAS NOT COMPLETELY DISCHARGED. WE WILL FILE A FOLLOW UP WITH THE EVALUATION, ONCE IT HAS BEEN INSPECTED.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS A OXYGEN CONCENTRATOR. EVALUATION OF THE PRODUCT WILL OCCUR AT THE SERVICE PROVIDERS ESTABLISHMENT. THERE IS LIMITED DATA DUE TO HIPPA RESTRICTIONS. SERVICE PROVIDER REPORTED THE CONSUMER BROKE THE XMAS TREE CONNECTOR ON THE DEVICE WHICH CAUSED IT TO BE INOPERABLE. HE WAS PROVIDED AN ALTERNATIVE OXYGEN SOURCE AND SERVICE PROVIDER TECHNICIAN WAS DISPATCHED. UPON ARRIVAL OF THE SERVICE PROVIDER'S TECHNICIAN AN AMBULANCE WAS ON SCENE AND PATIENT HAD EXPIRED. SERVICE PROVIDER TECHNICIAN REPORTED ALTERNATIVE OXYGEN SOURCE WAS NOT COMPLETELY DISCHARGED. WE WILL FILE A FOLLOW UP WITH THE EVALUATION ONCE IT HAS BEEN INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103452 DEVILBISS CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Death