BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 12567918 · Received October 4, 2021

    Report

    Report Number
    8010042-2021-02401
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 4, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT VENTILATOR GENERATED ALARM THAT INDICATES TOO LOW VOLUME DELIVERED. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, THE REPORTED ISSUE HAS NOT BEEN REPRODUCED. THE DEVICE PASSED ALL PERFORMANCE TESTS AND HAS BEEN RETURNED TO CLINICAL USE. THE DEVICE'S LOGS WERE NOT AVAILABLE FOR FURTHER EVALUATION. THE REPORTED PROBLEM WAS NOT DUPLICATED, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE CORRECTION OF FIELD #H4 DEVICE MANUFACTURE DATE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #H4 MANUFACTURE DATE: PREVIOUS MANUFACTURE DATE: 06/21/2005. CORRECTED MANUFACTURE DATE: 06/27/2005.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DELIVERED LOW VOLUME. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470749 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown