BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP A40

    MDR report key: 21403689 · Received February 18, 2025

    Report

    Report Number
    2518422-2025-102126
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 25, 2025
    Report Date
    February 3, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055186
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (NO EQUIPMENT NUMBER AVAILABLE) 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

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE HIGH INTERNAL O2 AND INTERRUPTION OR FAILURE OF THERAPY IN CERTAIN BIPAP A SERIES MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PRESSURE CONTROL, VENTILATOR OUT OF ORDER, AND INTERNAL O2 HIGH FOR THIS DEVICE. THE PATIENT WAS TAKEN TO THE HOSPITAL ALLEGEDLY FOR HYPOXIA AND RESPIRATORY DISTRESS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE BIPAP A40 PRO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE THIRD-PARTY SERVICE TECHNICIAN DID NOT ANY PARTS REPLACED OR MADE REPAIRS TO THE DEVICE SINCE THE THIRD-PARTY SERVICE TECHNICIAN WAS NOT ABLE TO REPRODUCE THE ISSUE ON THE DEVICE. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER BOX AIRWAY NEEDS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY NEEDS REPLACED DUE TO AN ERROR CODE, SOFTWARE UPGRADE PROCESS STARTED (E-0137), FOUND ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS ISSUE AS A PRODUCT PROBLEM IN THE TYPE OF REPORTED COMPLAINT FIELD, AND IT SHOULD HAVE BEEN REPORTED IT AS A SERIOUS INJURY. THE TYPE OF REPORTED COMPLAINT FIELD WAS CORRECTED TO SERIOUS INJURY.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE HIGH INTERNAL O2 AND INTERRUPTION OR FAILURE OF THERAPY IN CERTAIN BIPAP A SERIES MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PRESSURE CONTROL, VENTILATOR OUT OF ORDER, AND INTERNAL O2 HIGH FOR THIS DEVICE. THE PATIENT WAS TAKEN TO THE HOSPITAL ALLEGEDLY FOR HYPOXIA AND RESPIRATORY DISTRESS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52062 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. DEX3100S13 00606959055186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other