BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8321422 · Received February 8, 2019

    Report

    Report Number
    8010042-2019-00074
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    April 4, 2018
    Report Date
    June 14, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PERON: (B)(4). 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. THE TEST CONFIRMED THE REPORTED ISSUE, THE TECHNICAL ALARMS WERE REPRODUCED. 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 IT'S 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.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112152 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1