BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP PRO BIFLEX

    MDR report key: 24524803 · Received March 5, 2026

    Report

    Report Number
    2518422-2026-008190
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 17, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959011342
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    510K HAS BEEN UPDATED TO K091319.

    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 THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM DEGRADATION AND BLOWER FOAM DEGRADATION. THE DEVICE HAD DUST CONTAMINATION, AND UNIT WAS FUNCTIONAL. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207205 BIPAP PRO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS650HS 00606959011342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown