BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 17867684 · Received October 4, 2023

    Report

    Report Number
    8010042-2023-01925
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 15, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT INTERNAL LEAKAGE TEST FAILED DURING PRE-USE CHECK. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION. THE ISSUE WAS REPORTED TO COMPETENT AUTHORITY IN ABUNDANCE OF CAUTION AS INTERNAL LEAKAGE TEST FAILURE MAY IN SOME CASES, REPRESENT A REPORTABLE EVENT. FURTHER RECEIVED INFORMATION INDICATED THAT ONLY EXPIRATORY CASSETTE WAS REPLACED. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. WE DO NOT CONSIDER ISSUE WITH EXPIRATORY CASSETTE AS A SAFETY RELATED. EXPIRATORY CASSETTE ONLY MEASURING AND ITS MALFUNCTION WILL NOT AFFECT ONGOING VENTILATION. THERE WAS NO PATIENT INVOLVEMENT. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 893033

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526855 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown