BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 8001203 · Received October 24, 2018

    Report

    Report Number
    8010042-2018-00566
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). OUR COMPANY FIELD SERVICE ENGINEER (FSE) STATES THAT NO DEVIATIONS OR FAULTS COULD BE SEEN WHEN THE ANESTHESIA WORKSTATION WAS INVESTIGATED AT THE HOSPITAL. NO PARTS WERE REPLACED. THE UNIT WAS RETURNED TO CLINICAL USE. THE LOG CONTAINS ALARMS FOR HIGH PRESSURE BUT THE DATE OF THE ALLEGED EVENT IS NOT KNOWN. IT IS THEREFORE NOT POSSIBLE TO CONFIRM THE ALLEGED EVENT IN THE INTERNAL LOG. THERE ARE NO INDICATIONS OF ANY MALFUNCTIONS IN THE TECHNICAL LOG. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CASE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, ALARMS FOR HIGH AIRWAY PRESSURE WERE GENERATED. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842253 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1