BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 24513547 · Received March 4, 2026

    Report

    Report Number
    2518422-2026-007871
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 15, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055148
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED AS A FINAL REPORT AS THREE GOOD FAITH EFFORT PHONE CALL ATTEMPTS ON 04/01/2026, 4/07/2026, AND 04/010/2026, AND TO (B)(6). THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER HAS MADE SUFFICIENT ATTEMPTS FOR MORE INFORMATION AND THE RETURN OF THE DEVICE FOR EVALUATION, TO NO AVAIL. THIS REPORT IS BEING SUBMITTED AS A FINAL REPORT, HOWEVER IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, AN UPDATED FINAL REPORT WILL BE FILED. 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 AND CONSISTED OF A FIELD SAFETY NOTICE. 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 MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD A VENTILATOR INOPERATIVE CONDITION. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237481 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. ITX3100S21 00606959055148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown