BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 25113572 · Received May 7, 2026

    Report

    Report Number
    2518422-2026-012108
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 7, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055063
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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-1813-2024 AND CONSISTED OF A FIELD SAFETY NOTICE 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

    A BIPAP A40 PROEFL VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION IN BIPAP MECHANICAL VENTILATOR DEVICES. THERE WAS NO HARM OR INJURY REPORTED. REVIEW OF THE DEVICE ERROR LOG INDICATE VENTILATOR INOPERATIVE ERROR CODE E-47 INDICATING THE CENTRAL PROCESSING UNIT (CPU) CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SERIAL PERIPHERAL INTERFACE (SPI) BUS. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF WITHOUT REPAIR IN ACCORDANCE WITH PHILIPS FIELD CHANGE ORDER (B)(4). THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467611 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. GBX3100S19 00606959055063

    Patients

    Seq Age Sex Outcome Treatment
    1