BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 8455524 · Received March 27, 2019

    Report

    Report Number
    8010042-2019-00204
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 11, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR INVESTIGATED THE ANESTHESIA WORKSTATION AT THE HOSPITAL AND CONCLUDED THAT THE FRESH GAS PRESSURE TRANSDUCER WAS DEFECTIVE AND NEEDED TO BE REPLACED. AFTER THE REPLACEMENT, THE ANESTHESIA WORKSTATION WAS SUCCESSFULLY TESTED AND RETURNED TO CLINICAL USE. THE DEVICE LOGS WERE SAVED. THE REPLACED PART WAS DISCARDED BY THE TECHNICIAN. THE INVESTIGATION INTO THIS MATTER CONSISTS THEREFORE OF AN EVALUATION OF THE RECEIVED DEVICE LOGS ONLY. THE LOGS SHOW THAT SEVERAL UNSUCCESSFUL SYSTEM CHECK OUTS WERE PERFORMED ON THE REPORTED EVENT DAY. THE LOGS CONFIRM THE REPORTED SYSTEM CHECK OUT FAILURES AND THE TECHNICAL ERROR CODES. IT IS OUR CONCLUSION THAT THE REPLACED FRESH GAS PRESSURE TRANSDUCER CAUSED THE REPORTED ISSUES. WITHOUT ANY ADDITIONAL INFORMATION OR PARTS TO INVESTIGATE, WE ARE UNABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUES.

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSPIRATORY AND EXPIRATORY VALVE TEST FAILED DURING SYSTEM CHECK OUT. TECHNICAL ERROR CODES INDICATING A PRESSURE TRANSDUCER ERROR WERE GENERATED. THERE WAS NO PATIENT CONNECTED TO THE ANESTHESIA WORKSTATION DURING THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248221 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1