BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17389705 · Received July 25, 2023

    Report

    Report Number
    2518422-2023-16704
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    December 14, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A CORRECTIVE ACTION TO REPLACE MANUFACTURER REPORT # 2031642-2023-00105. ALL INFORMATION FROM THE ORIGINAL REPORT(S) HAS BEEN TRANSFERRED TO THIS REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED 05K/V60 VENTILATOR/HIGH EXH TV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921674 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY US MNT RESPIRONICS, INC. V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown