BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7498806 · Received May 9, 2018

    Report

    Report Number
    8010042-2018-00226
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    September 4, 2017
    Report Date
    September 7, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD HAS BEEN COMPLETED. THIS BOARD CONTAINS ELECTRONICS WHICH INCLUDE MICROPROCESSOR FOR CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION OF THE DEVICE. THE REPORTED FAILURE MODE WAS CONFIRMED IN THE RECEIVED DEVICE LOGS. THE PC-BOARD WAS INSTALLED IN A REFERENCE SYSTEM FOR SIMULATED USE TESTING. TEST VENTILATION CONFIRMED THE REPORTED ISSUE. ELECTRICAL MEASUREMENTS ON THE EXPIRATORY CHANNEL PC BOARD SHOWED THAT A CAPACITOR IN THE PULL MAGNET SUPPLY CIRCUIT WAS SHORTED, WHICH CAUSED THE SAFETY VALVE TO ALWAYS BE IN OPEN STATE. A FAILURE IN THE PULL MAGNET SUPPLY CIRCUIT CAN LEAD TO STOP OF VENTILATION IF THE SAFETY VALE IS NOT IN ITS PREDETERMINED STATE. APPEARANCE OF THIS FAILURE WILL BE NOTIFIED TO THE USER BY GENERATED HIGH PRIORITY ALARMS AND A TECHNICAL ERROR CODE. IF THE FAULT IS PRESENT IT WILL BE DETECTED DURING PRE-USE CHECK. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED ISSUE WAS CAUSED BY A SHORTED CAPACITOR ON THE EXPIRATORY CHANNEL PC BOARD, THAT IS PART OF THE SAFETY VALVE FUNCTION. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR DISPLAYED TECHNICAL ERROR CODES FOR POWER ERROR AND SAFETY VALVE OPEN. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342948 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1