BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP PRO BIFLEX

    MDR report key: 24484802 · Received March 2, 2026

    Report

    Report Number
    2518422-2026-007316
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 23, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005945
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT TO CORRECT OUR PREVIOUS SUBMISSION. UPDATED THE FOLLOWING: 510 K (K131982), B5, DEVICE SERVICED BY THIRD-PARTY (YES), DEVICE AVAILABLE FOR EVALUATION (NO), REPORT SOURCE- COMPANY REPRESENTATIVE AND OTHER- THIRD-PARTY SERVICE CENTER, 510K (RFB)-K131982, REASON FOR DEVICE NOT EVALUATED (OTHER), REASON- DEVICE EVALUATED BY THIRD PARTY SERVICE CENTER, AND DEVICE AVAILABLE FOR EVALUATION (NO),

    Description of Event or Problem · 0

    A BIPAP PRO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND BLOWER FOAM DEGRADATION. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Description of Event or Problem · 0

    A BIPAP PRO BIFLEX DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED OBJECT CODE INDICATES THE BLOWER CONTRIBUTED TO THE FOAM DEGRADATION. ADDITIONALLY, THE DEVICE HAD DUST FAIL CONTAMINATION. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68735 BIPAP PRO BIFLEX VENTILATOR NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS660S 00606959005945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown