BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 7237597 · Received February 2, 2018

    Report

    Report Number
    2515872-2018-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    November 21, 2017
    Report Date
    December 1, 2017
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    LEL
    UDI-DI
    00885304000051
    PMA / PMN Number
    K112220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED THAT A CPAP UNIT, MODEL DV54UK-P SERIAL (B)(4), WITH HEATER MODEL DV5HH SERIAL (B)(4), AND SMARTLINK MODEL SV5M SERIAL (B)(4) WERE RETURNED BY THE PATIENT. THE (B)(4) DISTRIBUTOR INITIALLY REPORTED THAT PATIENT'S CPAP "BEGAN TO SMOKE IN THE NIGHT AND [SMOKE] CAME THROUGH THE MASK." HOWEVER, UPON FURTHER COMMUNICATION BETWEEN (B)(4) DISTRIBUTOR AND THE PATIENT, IT WAS DETERMINED THE UNIT STOPPED OPERATING ONCE THE SMOKE STARTED AND THE PATIENT HAD NO COMPLAINT OF INJURY OR HEALTH-RELATED ISSUES DUE TO THE INCIDENT. THE UNIT WAS RETURNED TO DEVILBISS HEALTHCARE AND AN ENGINEERING INSPECTION AND EVALUATION WAS PERFORMED. THE RESULTS OF THAT INVESTIGATION INDICATED THAT THE CPAP UNIT FAILURE WAS CAUSED BY A LIQUID SUBSTANCE ONTO/ INTO THE ELECTRONIC ASSEMBLY. THE UNIT WAS IN USE FOR ABOUT 12 MONTHS AND THE LIQUID SUBSTANCE ON THE ELECTRONIC ASSEMBLY WAS LIKELY CAUSED BY A SPILL WHEN IN USE.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED A CPAP UNIT, MODEL DV54UK-P, MALFUNCTIONED AND "CAUSED MINOR RESPIRATORY IRRITATION TO THE PATIENT". PATIENT ARRIVED AT THE HOSPITAL WITH HIS CPAP UNIT BUT THERE WAS NO INDICATION OF THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE (B)(6) DISTRIBUTOR STATED THE PATIENT REPORTED "THE CPAP UNIT HAD STOPPED FUNCTIONING AND SMOKE STARTED TO COME OUT THROUGH THE MASK. IT WAS AT THIS POINT THE CPAP DEVICE STOPPED WORKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80617 DEVILBISS INTELLIPAP UNIT LEL DEVILBISS HEALTHCARE LLC DV54UK-P 00885304000051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR