BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 22344475 · Received June 27, 2025

    Report

    Report Number
    8010042-2025-0000979
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Report Date
    June 27, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, EVEN AFTER THE RESTART OF THE VENTILATOR, THE TECHNICAL ERROR PERSISTED. THE DEVICE WAS REPAIRED BY THIRD PARTY SERVICE. THERE WAS NO ON-SITE VISIT BY OUR TECHNICIAN. NO DETAILS WERE PROVIDED REGARDING FINAL SOLUTION OF THE ISSUE. GENERATED TECHNICAL ERROR INDICATES THAT THE SAFETY VALVE IS DETECTED AS OPEN WITHOUT FULFILLED OPENING CONDITIONS. A SAFETY VALVE OPEN ALARM SHALL BE TRIGGERED WHEN A LOW LEVEL OF THE SIGNAL SAFETY VALVE CLOSED IS DETECTED FOR MORE THAN 8 SEC AND BEFORE 10 SEC. THE DEVICE'S LOGS WERE NOT PROVIDED FOR FURTHER ANALYSIS. AS THE FINAL SOLUTION IS UNKNOWN, THE CAUSE OF THE FAILURE WAS NOT DETERMINED. THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER AND MANUFACTURE DATE CAN BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127082 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown