BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8855032 · Received August 2, 2019

    Report

    Report Number
    8010042-2019-00571
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 29, 2019
    Report Date
    May 19, 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

    OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. THE REPORTED ERRORS ARE INDICATING COMMUNICATION OR CONTROL PRINTED CIRCUIT BOARD (PCB) ERROR DURING START UP AND INTERNAL MEMORY ERROR. AS A REMEDY FOR BOTH ERRORS, THE SERVICE MANUAL RECOMMENDS CONTROL PCB TO BE REPLACED. FSE REPLACED THE PCB AND THE VENTILATOR PASSED ALL THE FUNCTIONAL AND SAFETY TESTS AND RETURNED TO CLINICAL USE. THE LOGS COULD NOT BE PROVIDED BY THE FSE. THE HOSPITAL KEPT THE FAULTY PART. THEREFORE FURTHER INVESTIGATION WAS NOT POSSIBLE. THE ROOT CAUSE OF THE REPORTED ERRORS IS THE FAULTY PCB BOARD HOWEVER IT WAS NOT POSSIBLE TO FIND THE REASON OF IT BEING FAULTY WITH THE EXISTING INFORMATION.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 233447.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR A COMMUNICATION ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651830 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1