BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A30

    MDR report key: 25095055 · Received May 6, 2026

    Report

    Report Number
    2518422-2026-011707
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 6, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959067493
    PMA / PMN Number
    K113053
    Removal / Correction Number
    Z-1814-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE OF VENTILATOR INOPERATIVE IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION LOSS OF FUNCTION/LOSS OF PRIMARY FUNCTION. A FIELD ACTION WAS INITIATED WITH RECORD ID Z-1814-2024 AND CONSISTED OF A FIELD SAFETY NOTICE FSN 2023-CC-SRC-039. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO FURTHER INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES.

    Description of Event or Problem · 0

    THE BIPAP A30 PRO VENTILATOR WAS EVALUATED AT THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DURING THE EVALUATION A VENTILATOR INOPERATIVE ERROR CODE WAS NOTED IN THE ERROR LOG INDICATING FAILURE OF THE OUTLET PRESSURE SENSOR. THE DEVICE'S CIRCUIT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575217 BIPAP A30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1111143 00606959067493

    Patients

    Seq Age Sex Outcome Treatment
    1