BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8943692 · Received August 29, 2019

    Report

    Report Number
    8010042-2019-00629
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 25, 2019
    Report Date
    March 25, 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

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). THE REPORTED TECHNICAL ERROR CODE COULD BE DUPLICATED. AS RECOMMENDED IN THE SERVICE MANUAL FOR THIS ERROR MESSAGE, THE EXPIRATORY CHANNEL PC (PRINTED CIRCUIT) BOARD WAS REPLACED BUT NOT RETURNED FOR INVESTIGATION. THE VENTILATOR PASSED FUNCTIONAL AND PRE-USE CHECKS AND WAS CLEARED FOR CLINICAL USE. PROVIDED VENTILATOR LOGS CONFIRM THE GENERATED A TECHNICAL ERROR CODE INDICATING AN OPEN SAFETY VALVE. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED TECHNICAL ERROR CODE HAS NOT BEEN DETERMINED, BUT THE REPLACED EXPIRATORY CHANNEL PC BOARD WAS MOST LIKELY CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 241364.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-USE CHECK, THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN OPEN SAFETY VALVE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737213 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1