BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 9237097 · Received October 25, 2019

    Report

    Report Number
    8010042-2019-00782
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    May 14, 2020
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO VENTILATOR LOGS HAVE BEEN PROVIDED AND NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE USER FACILITY. INFORMATION ABOUT THE CURRENT STATUS OF THE VENTILATOR HAS NOT BEEN PROVIDED. NO INVESTIGATION HAS BEEN POSSIBLE, THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. H3 OTHER TEXT : 4117.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 260342.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR INDICATING A POWER ERROR. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036611 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1