BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010042-2018-00434

    MDR report key: 7804540 · Received August 22, 2018

    Report

    Report Number
    8010042-2018-00434
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 10, 2018
    Report Date
    September 25, 2018
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    OUR FIELD SERVICE ENGINEER (FSE) COULD NOT REPRODUCE THE REPORTED ISSUE. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. PROVIDED VENTILATOR LOGS WERE REVIEWED. AN ALARM FOR AN ERROR IN THE INTERNAL MEMORY WAS FOUND GENERATED DIRECTLY AFTER SYSTEM STARTUP TOGETHER WITH TWO OTHER ALARMS FOR SOFTWARE CHECKSUM ERROR AND SYSTEM ID CONFLICT DURING STARTUP. THIS IS AN ERROR CODE FOR VENTILATION STOPPED AND IS RELATED TO AN INTERNAL MEMORY ERROR. IT CAN OCCUR AT STARTUP AFTER A SOFTWARE INSTALLATION. IT IS STATED IN THE SERVICE MANUAL THAT IF THE ALARM DISAPPEARS AND NO OTHER TECHNICAL ALARMS ARE GENERATED AFTER RESTART THE PROBLEM WAS OF MOMENTARILY NATURE. IF THE ALARM PERSISTS OR IF OTHER TECHNICAL ALARMS ARE GENERATED IT INDICATES A HARDWARE ERROR. AFTER THE ALARM HAD BEEN GENERATED THE SYSTEM WAS RESTARTED AND A PRE-USE CHECK WAS PERFORMED. THE PRE-USE CHECK WAS SUCCESSFUL AND NO TECHNICAL ALARMS WERE GENERATED. HENCE, THE ALARM WAS MOMENTARILY. THE TRUE ROOT CAUSE OF THE INTERNAL MEMORY ERROR HAS NOT BEEN DETERMINED. 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 WHEN CONNECTED TO A PATIENT, THE VENTILATOR GENERATED AN ALARM FOR AN ERROR IN THE INTERNAL MEMORY. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Patients

    Seq Age Sex Outcome Treatment
    1