BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO BIFLEX

    MDR report key: 13760073 · Received March 14, 2022

    Report

    Report Number
    2518422-2022-09465
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    September 25, 2019
    Report Date
    October 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959036468
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, OCCURED. AFTER REVIEW, IT WAS DETERMINED THAT THIS OPTION WAS INCORRECTLY SELECTED. NOTHING SUCH HAS OCCURED TO THE PATIENT. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY. PMA/510(K) NUMBER WAS INCORRECT THE CORRECT VALUE IS K050759. INITIAL REPORTER AND BRAND NAME ARE UPDATED.

    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.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK PARTICLES IN BIPAP DEVICE. 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
    282719 BIPAP AUTO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN751S 00606959036468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention