BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4801819 · Received May 26, 2015

    Report

    Report Number
    8010042-2015-00198
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET'S FIELD SERVICE ENGINEER HAS INVESTIGATED THE VENTILATOR ON-SITE, AND THE AIR GAS MODULE WAS FOUND TO BE DEFECTIVE. THE AIR GAS WAS REPLACED, AND WILL BE RETURNED TO FACTORY FOR INVESTIGATION. FURTHER INFO ABOUT THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE RETURNED AIR GAS MODULE WHICH REGULATES THE INSPIRATORY AIR GAS FLOW TO THE PATIENT HAS BEEN INVESTIGATED. THE PC-BOARD WAS INSTALLED IN A REFERENCE SYSTEM FOR SIMULATED USE TESTING. THE PRE-USE CHECK FAILED THE PRESSURE TRANSDUCER TEST AND FLOW TRANSDUCER TEST THAT CONFIRMS THE REPORTED DESCRIPTION. THE OCULAR INSPECTION OF THE AIR-GAS MODULES INTERNAL PC-BOARD FOUND THREE CAPACITOR THAT WAS NOT ADEQUATELY SOLDER TO THE PRINTED CIRCUIT BOARD. THE CAPACITORS IS PART OF THE ELECTRONICS FOR REGULATION OF FLOW AND PRESSURE. THE CONCLUSION IS THAT THE UNSOLDERED CAPACITORS WAS THE CAUSE OF THE REPORTED ISSUE. THE ROOT CAUSE OF WHY THIS CAPACITORS WAS NOT SOLDER TO THE PRINTED CIRCUIT BOARD HAS NOT BEEN DETERMINED. EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS THE REPORTED ALARMS AND WE COULD TRACE BACK THE REPORTED PROBLEM TO MAY 5, THEREFORE THE DATE OF EVENT WAS DETERMINED AS (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRESSURE TRANSDUCER TEST AND FLOW TRANSDUCER TEST DURING PRE-USE CHECK (AUTOMATIC FUNCTION CHECK THAT IS RUN BEFORE CONNECTING THE VENTILATOR TO A PT). (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340433 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1