BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 21921896 · Received April 28, 2025

    Report

    Report Number
    2518422-2025-104896
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 28, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959067677
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE CONDITION HAD OCCURRED WHILE PERFORMING THE RUN-IN TEST ON THE BIPAP A40 DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN REPLACED THE DEVICE'S AV2/OAP MAIN PRINTED CIRCUIT ASSEMBLY BOARD TO ADDRESS THE ISSUE. AFTER REPLACING THE PART ON THE DEVICE, THE THIRD-PARTY SERVICE TECHNICIAN UPGRADED THE SOFTWARE VERSION ON THE DEVICE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE SEVERAL LOG ONLY ERRORS (E-016, E-051, E-068, E-083, E-087, E-097, E-098, E-099, E-100, E-101, E-102, E-103, E-104, E-166, E-170, AND E-204), INFORMATIONAL MESSAGES (E-081 AND E-163) THAT WERE FOUND ON THE DEVICE. THE WERE ADDITIONAL SYSTEM ERRORS THAT WERE FOUND ON THE DEVICE, AS FOLLOW: E-042 (APNEA ERROR), E-057 (AC DISCONNECT), E-058 (EXTERNAL BATTERY), AND E-072 (BEEP ONLY). IN ADDITION, THERE WAS DUST/DIRT CONTAMINATION FOUND INSIDE THE DEVICE. SINCE THESE ARE CONSIDER INFORMATIONAL PURPOSE MESSAGES, THERE WERE NO PARTS REPLACE TO ADDRESS THESE SYSTEM ERRORS. AFTERWARDS, THE DEVICE WAS TESTED AND WAS OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757038 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. 1111169 00606959067677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown