BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 20960688 · Received December 18, 2024

    Report

    Report Number
    2518422-2024-074706
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    December 28, 2023
    Report Date
    May 12, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT, THE MANUFACTURER CAPTURED INCORRECT INFORMATION IN BOX E. THE FOLLOWING CORRECTION HAS BEEN UPDATED IN THIS REPORT. IN BOX E: REPORTER COUNTRY HAS BEEN CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A DS2ADV AUTO CPAP WITH AN ALLEGATION OF SERVICE REQUIRED AND WILL NOT TURN ON. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION AND OBSERVED THE 1142687-431 DS2 REUSABLE POLLEN FILTER BY SERVICE 1149563-431 DREAMSTATION2 BLOWER CONTAMINATE. ED 1149561-431 DS2 BLOWER OUTLET SEAL/ISOLATOR KIT CONTAMINATED 1149569-431 DREAM STATION 2 BLOWER BOX KIT CONTAMINATED 1149571-43 1 DREAM STATION 2 ISO PORT KIT, PLUS CONTAMINATED 1149612-431 DREAM STATION 2 AUTO CPAP ADVANCE W/MODEM, DOM, PCA WITH DAMAGE 11428 36-431 DS2 INLET/OUTLET SEAL CONTAMINATED 1149560-431 DREAM STATION 2 UI BEZEL PLUS WITH PHYSICAL DAMAGE. PCA BURN. THE CUSTOMER COMPLAINT WAS REPRODUCED. THERE WERE MULTIPLE ERRORS HAVE BEEN IDENTIFIED. THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720432 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown