BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 21560916 · Received March 10, 2025

    Report

    Report Number
    2518422-2025-102810
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    October 15, 2024
    Report Date
    May 26, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959067677
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (UPDATE MATERIAL # FROM RA) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

    Additional Manufacturer Narrative · 0

    DESPITE THREE GOOD FAITH EFFORT EMAIL ATTEMPTS ON 6/16/2025 AND 6/23/2025 TO EMAIL (B)(6), AND BY PHONE ON 03/312026 TO (B)(6), THE DEVICE SERIAL NUMBER IDENTIFICATION WAS NOT ABLE TO BE OBTAINED, AND THE DEVICE HAS NOT 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 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.

    Additional Manufacturer Narrative · 0

    THE BECOME AWARE DATE HAS BEEN CORRECTED BASED ON QUALITY REVIEW; THE REPORT DUE DATE IS RE-CALCULATED TO REFLECT MARCH 27, 2025. AS THIS COMPLAINT RECORD HAS ALREADY BEEN REPORTED PRIOR TO THE NEWLY CALCULATED DUE DATE, NO ACTION OTHER THAN THIS CORRECTION IS REQUIRED.

    Description of Event or Problem · 0

    THIS NOTIFICATION WAS OPENED DUE TO A REPORT THAT A PHILIPS RESPIRONICS A40 PRO VENTILATOR RESET TO FACTORY SETTINGS RESULTING IN INADEQUATE PATIENT VENTILATION. THE NON-VENTILATOR-DEPENDENT PATIENT USED THE A40 PRO HOME VENTILATOR OVERNIGHT. ON THE NIGHT OF (B)(6) 2024, THE VENTILATOR WAS REPORTED TO HAVE STOPPED WORKING AND SHOWED A VENTILATOR INOPERABLE ALARM. (SEE THE URGENT FIELD SAFETY NOTICE 2023-CC-SRC-039.) THE PATIENT WAS GUIDED THROUGH THE HARD REBOOT PROCESS (AS PER FSN) OVER THE PHONE BY A SPECIALIST NURSE. THE HARD REBOOT APPEARED TO RESOLVE THE ISSUE. THE PATIENT USED THE VENTILATOR ON THE NIGHT OF (B)(6) 2024, BUT STATED THEY FELT SUFFOCATED AND INCREASINGLY UNWELL, SO THEY STOPPED USING IT. THE SPECIALIST NURSE VISITED THE PATIENT'S HOME ON (B)(6) 2024 TO ASSESS THE DEVICE. THE VENTILATOR SETTINGS HAD BEEN RESET TO THE FACTORY DEFAULT SETTINGS, MEANING THE PATIENT HAD BEEN VENTILATED USING THE WRONG MODE AND MUCH LOWER PRESSURES THAT WERE INSUFFICIENT TO TREAT THIS PATIENT. RESETTING THE SETTINGS TO THE FACTORY DEFAULT IS NOT LISTED AS A KNOWN ISSUE IN THE FSN BUT WAS LATER VERBALLY CONFIRMED BY A PHILIPS RESPIRONICS EMPLOYEE. THIS NOTIFICATION WAS REVIEWED BY A PHILIPS POST-MARKET SURVEILLANCE CLINICAL EXPERT AND BASED ON INFORMATION AVAILABLE AT THIS TIME, THE REPORTED EVENT HAS BEEN ASSESSED AS A NON-SERIOUS INJURY. THEREFORE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. NO FURTHER ACTION IS REQUIRED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ADDITIONAL INFORMATION IS OBTAINED ABOUT THIS EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED. INCIDENT REPORT NUMBER ASSIGNED BY NCA FOR THIS INCIDENT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360545 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. 1111169 00606959067677

    Patients

    Seq Age Sex Outcome Treatment
    1