BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 13962424 · Received March 31, 2022

    Report

    Report Number
    2518422-2022-04972
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    September 24, 2020
    Report Date
    July 8, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959022546
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN INCORRECT DATE IN SECTION G3 AS 09/25/2020, THE CORRECT DATE IN G3 SHOULD BE 09/24/2020. AND INCORRECT DATE IN SECTION B3 AS 09/25/2020, THE CORRECT DATE IN B3 SHOULD BE 09/24/2020.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLE CONTAMINATION IN BLOWER WAS OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189977 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700T11 00606959022546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown