BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 18980219 · Received March 26, 2024

    Report

    Report Number
    2518422-2024-14878
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    October 1, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE INFORMATION WAS PROVIDED, THE EXACT RECALL NUMBER IS UNKNOWN. POSSIBLE RECALL NUMBERS INCLUDE Z-1972-2021, Z-1973-2021, AND Z-1974-2021. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5152151) IN WHICH THE PATIENT ALLEGES THE DEVICE TO OVERHEAT AND EMIT A BAD SMELL. PATIENT STATED THAT THIS HAPPENS CONSTANTLY INCONSTANT, ABOUT THREE TIMES A MONTH. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4600 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown