BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 13625290 · Received February 28, 2022

    Report

    Report Number
    2518422-2022-05158
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    January 27, 2021
    Report Date
    January 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    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 WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE I RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP. BIPAP. AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THERE WAS NO MENTION OF VISUAL FINDING TO THE EXTERNAL PART OF THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE 4 ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2022-05158-1. PLEASE DISREGARD MDR 2518422-2022-05158-1 AS IT WAS FILED IN ERROR.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE BIPAP DEVICE'S SOUND ABATEMENT FOAM. 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
    1299170 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 950P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown