BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP A40 PRO

    MDR report key: 18764583 · Received February 22, 2024

    Report

    Report Number
    2518422-2024-09335
    Event Type
    Death
    Date Received
    February 22, 2024
    Date of Event
    September 8, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055025
    PMA / PMN Number
    K121623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED AND THE PATIENT DYING WHILE ON THE DEVICE. A LAB INVESTIGATION WAS PERFORMED AND STATED, "PIL VISUALLY INSPECTED THE BI-PAP A40 PRO AND DID NOT OBSERVE ANY VISUAL DEFECTS. IN ADDITION, THE TECH VERIFIED THAT THE UNIT WAS OPERATING ON SW VERSION 1.1.2.0 AT THE TIME OF THE EVENT. DURING THE PIL REVIEW OF THE LOG THE PIL VERIFIED MULTIPLE E96'S HAD OCCURRED WITH AN INCORRECT DATE OF (B)(6) 1970, OCCURRING BEFORE AN SD CARD INSERT ON (B)(6) 2022. THE PIL COULD ALSO CONFIRM A VENTILATOR INOPERATIVE SHOWING A DATE OF (B)(6) 2022 02:11 AM IN THE ALARM LOG OF THE DISPLAY IN THE UNIT ALARM LOG. HOWEVER, THE VENT INOP DOES NOT SHOW IN THE LOG. TECH VERIFIED THAT THE UNIT OPERATES AT THE PIL WITHOUT ISSUE OR ERROR CODE DURING UNIT OPERATION AT THE PIL. DUE TO THE UNIT MULTIPLE E96'S NOTED IN THE LOG AND THE VENT INOP NOTED IN THE ALARM LOG OF THE UNIT, THE PIL TECH REACHED OUT TO ENGINEERING. ENGINEERING HAS ADDED A INTERLEAVED LOG TO SHOW THE LOG ENTRIES THAT ARE CORRUPT. PER ENGINEERING , THIS IS A SOFTWARE ISSUE, FALLING UNDER EXISTING INVESTIGATIONS. EXTENSIVE INVESTIGATIONS HAVE TURNED UP EVIDENCE OF SERIAL FLASH WRITES FAILING/HANGING, POSSIBLY ASSOCIATED WITH MULTIPLE SLEEP EVENTS GETTING QUEUED UP WITHOUT BEING PROCESSED SO THAT THERE'S A QUEUE OVERFLOW OR DEADLOCK. PER ENGINEERING THIS HAS BEEN VERIFIED AS A SOFTWARE ISSUE AND IS BEING FURTHER EVALUATED BY ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212229 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. INX3100S19 00606959055025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death