BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 12905438 · Received November 30, 2021

    Report

    Report Number
    2515872-2021-00021
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 30, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304022466
    PMA / PMN Number
    K071397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A REPORT OF A DEFECTIVE CONCENTRATOR FROM A CONSUMER; UPON START UP THE YELLOW LIGHT COMES ON THEN GOES IMMEDIATELY TO RED. HE SHIPPED IT FOR REPAIR ON (B)(6) WITH 125 HOURS ON IT. THEY DID THE REPAIR, LOST HIS BOX, AND SCRATCHED THE FRONT OF MACHINE. IT TOOK 2 MONTHS TO RECEIVE IT BACK. THE UNIT NOW HAS 142 HOURS ON IT AND IS NOT WORKING AGAIN. HE STATES THAT THE UNIT WHICH HAS BEEN BROKEN MORE THAN HE HAS USED IT. HE DOES NOT WANT TO BEAR THE BURDEN OF COST TO SHIP IT FOR REPAIR. HE HAS BEEN USING THE CONCENTRATOR IN CONJUNCTION WITH A HYPERBARIC CHAMBER WHICH IS NOT AN AUTHORIZED ACCESSORY FOR THIS UNIT NOR ITS INTENDED USE. THE UNIT WAS BEING USED IN AN APPLICATION UNFAMILIAR TO US; IN CONJUNCTION WITH A HYPERBARIC CHAMBER THAT WE HAVE NO TECHNICAL SPECIFICATIONS OR OTHER INFORMATION TO DETERMINE HOW, IF AT ALL THE CHAMBER MIGHT OPERATE WITH OUR DEVICE OR OTHER OXYGEN DEVICES. THE DEVICE IS BEING USED OFF-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800925 DEVILBISS PORTABLE OXYGE CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 1025DS 00885304022466

    Patients

    Seq Age Sex Outcome Treatment
    1 Male