BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 17132992 · Received June 15, 2023

    Report

    Report Number
    8010042-2023-01130
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 15, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL EVALUATION DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF REPORT WITH MFG REPORT NUMBER: 8010042-2023-01143. THE CORRECTION OF FIELD VERSION OR MODEL #, CATALOG #, SERIAL#, MANUFACTURE DATE AND PMA/510(K)# WERE REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. VERSION OR MODEL # PREVIOUS VERSION OR MODEL #: SERVO-I. CORRECTED VERSION OR MODEL #: SERVO-U. CATALOG # PREVIOUS CATALOG #: 6487800. CORRECTED CATALOG #: 6694800 SERIAL# PREVIOUS SERIAL#: 85177 CORRECTED SERIAL#: 42757 MANUFACTURE DATE PREVIOUS MANUFACTURE DATE: 11/09/2016 CORRECTED MANUFACTURE DATE: 01/19/2021 PMA/510(K)# PREVIOUS PMA/510(K)#: K123149 CORRECTED PMA/510(K)#: K201874

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR'S HUMIDIFIER HOLDER WAS BROKEN.THERE WAS NO PATIENT HARM.MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281711 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown