BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 7788720 · Received August 16, 2018

    Report

    Report Number
    8010042-2018-00422
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 30, 2018
    Report Date
    January 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    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

    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). THE ANESTHESIA WORKSTATION WAS INVESTIGATED AT THE HOSPITAL BY OUR COMPANY REPRESENTATIVE. IT WAS CONCLUDED THAT THE FRESH GAS PRESSURE TRANSDUCER NEEDED TO BE REPLACED. THE LOGS WERE DOWNLOADED AND SENT FOR EVALUATION. THE REPLACED FRESH GAS PRESSURE TRANSDUCER WAS NOT RETURNED FOR INVESTIGATION. THE LOGS CONFIRM THE REPORTED ISSUES WITH FAILING SYSTEM CHECK OUT (SCO) AND GENERATION OF A TECHNICAL ERROR CODES ON THREE DIFFERENT OCCASIONS. THE EVENT LOG CONTAINS SEVERAL CLINICAL ALARMS ON THE SAME OCCASIONS SUGGESTING THAT THE VENTILATION OF THE PATIENT WAS INSUFFICIENT AT THOSE TIMES. THE LOG ALSO SHOWS THAT THE LAST SUCCESSFUL SCO WAS PERFORMED 13 DAYS BEFORE THE EVENT. THE CAUSE OF THE SCO FAILURES, THE TECHNICAL ERRORS AND THE INSUFFICIENT VENTILATION WAS THE REPLACED FRESH GAS PRESSURE TRANSDUCER WHICH HAD A ZERO PRESSURE OFFSET VALUE AT 0 MV INSTEAD OF THE NORMAL 2000MV. WE HAVE NOT BEEN ABLE TO DETERMINE WHY THE ZERO PRESSURE OFFSET VALUE WAS INCORRECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION GENERATED A TECHNICAL ERROR CODE INDICATING A PRESSURE TRANSDUCER ISSUE. THERE IS NO INFORMATION WHETHER THE ISSUE OCCURRED DURING PATIENT TREATMENT OR NOT. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629199 FLOW-I C30 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C30

    Patients

    Seq Age Sex Outcome Treatment
    1