BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 21101259 · Received January 8, 2025

    Report

    Report Number
    2518422-2025-000689
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    April 15, 2024
    Report Date
    July 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED DS2ADV AUTO CPAP W/HUMID CELL/BT. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DRYNESS, NOSE BLEEDS, AND TEETH PAIN FOR SEVERAL WEEKS. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTRE. AND OBSERVED HUMIDIFIER HAS CONTAMINATION AND PCA WITH DAMAGE IN LED'S DIM BRIGHT, HUMIDIFIER WATER TANK CONTAMINATED, DREAMSTATION2 BLOWER CONTAMINATED, BLOWER OUTLET SEAL/ISOLATOR KIT CONTAMINATED, BLOWER BOX KIT CONTAMINATED, AUTO CPAP ADVANCE W/MODEM WITH ELECTRICAL DAMAGE, INLET/OUTLET SEAL CONTAMINATED, WARNING LABEL WITH STAINS, HEATER PLATE KIT WITH ELECTRICAL DAMAGE. THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. THERE WAS NO ERROR HAS BEEN IDENTIFIED. IN BOX H EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID AND CONCLUSION CODE GRID WERE UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED DS2ADV AUTO CPAP W/HUMID CELL/BT THE MANUFACTURER RECEIVED INFORMATION ALLEGING DRYNESS, NOSE BLEEDS, AND TEETH PAIN FOR SEVERAL WEEKS. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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
    1322719 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male