BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-AIR LITE

    MDR report key: 21729768 · Received March 31, 2025

    Report

    Report Number
    8010042-2025-0000499
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Report Date
    March 31, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    MNT
    UDI-DI
    07325710015117
    PMA / PMN Number
    K230173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF REPORT WITH MFG REPORT NUMBER: 8010042-2025-0000357. THEREFORE, FOR EVALUATION RESULTS AND MANUFACTURE¿S NARRATIVE PLEASE REFER TO THIS REPORT.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD A TURBINE FAILURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912270 SERVO-AIR LITE VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT MAQUET CRITICAL CARE AB 6893200 07325710015117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown