BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8133276 · Received December 5, 2018

    Report

    Report Number
    8010042-2018-00654
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 16, 2018
    Report Date
    March 19, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    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). DURING A SOFTWARE INSTALLATION THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES INDICATING POWER FAILURE. THE VENTILATOR WAS INVESTIGATED AND THE MONITORING PRINTED CIRCUIT BOARD (PCB) AND THE EXPIRATORY CHANNEL PCB WERE REPLACED AND RETURNED FOR INVESTIGATION. THE MONITORING PCB WAS FOUND WORKING AS EXPECTED DURING SIMULATED USE TEST. THE EXPIRATORY CHANNEL PCB WAS ALARMING FOR COMMUNICATION PROBLEM DURING SIMULATED USE TEST. THE FAILURE WAS CAUSED BY A DEFECTIVE CENTRAL PROCESSOR UNIT (CPU) ON A PRINTED CIRCUIT BOARD. OUR CONCLUSION IS THAT DURING THE EVENT THE CPU WAS IN THE PROCESS TO BREAK AND THIS LEAD TO AN OVERHEATING OF A COIL ON THE +12V LINE DUE TO A SHORT CIRCUIT. THE VENTILATOR GENERATED TECHNICAL ERROR INDICATING POWER FAILURES WHEN THE COIL BREAKS DOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES INDICATING POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972627 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1