BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8797554 · Received July 17, 2019

    Report

    Report Number
    8010042-2019-00501
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 19, 2019
    Report Date
    March 19, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. NO FURTHER INFORMATION HAS BEEN RECEIVED SUCH AS SERVICE MEASURES, LOG FILES OR GOODS. AS NO GOODS WERE RETURNED FOR INVESTIGATION AND NO INFORMATION REGARDING THE SERVICE MEASURES OR LOG FILES HAS BEEN RECEIVED, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF.: 221152.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592267 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1