BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 20952788 · Received December 17, 2024

    Report

    Report Number
    2518422-2024-074767
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    October 9, 2023
    Report Date
    September 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424173
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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,Z-1973, AND Z-1974.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: 510K: UPDATED TO K131982. 510K (RFB): REQUIRED. PRODUCT BRAND NAME: UPDATED TO DREAMSTATION AUTO CPAP . MODEL NUMBER (RFB): REQUIRED. MODEL NUMBER: UPDATED TO DSX500S11. CATALOG ITEM IDENTIFIER (RFB): REQUIRED. CATALOG ITEM IDENTIFIER: UPDATED TO DSX500S11. SERIAL NUMBER (RFB): REQUIRED. SERIAL NUMBER: UPDATED TO (B)(6). PRODUCT UDI (RFB): REQUIRED. PRODUCT UDI: UPDATED TO (B)(4). MANUFACTURE DATE: 11/06/2018. MANUFACTURE DATE (RFB): REQUIRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/31/2022, AND SECTION H11 SHOULD BE REPORTED AS: THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION CANCER. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING EVALUATION SECONDARY FINDINGS WERE OBSERVED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED. IN BOX A: PATIENT IDENTIFIER WAS INCORRECTLY CAPTURED IN PREVIOUS REPORT, AND IT WAS CORRECTED IN THIS REPORT. IN BOX E: INITIAL REPORTER DETAILS WERE MISSED TO CAPTURED IN PREVIOUS REPORT AND IT WAS UPDATED IN THIS REPORT. IN BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE, COMPONENT CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION CANCER. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292598 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500S11 00606959424173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other