BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I

    MDR report key: 8335290 · Received February 13, 2019

    Report

    Report Number
    8010042-2019-00083
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 17, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED TO PROVIDE GAS TO THE PATIENT. NO ADDITIONAL INFORMATION SURROUNDING THE EVENT HAS BEEN PROVIDED. THE DEVICE LOGS WERE RECEIVED AND THE EVALUATION OF THE LOGS SHOW THAT CLINICAL ALARMS SUCH AS LEAKAGE, EXPIRATORY MINUTE VOLUME: LOW, RESPIRATORY RATE: HIGH INDICATES THAT LEAKAGES CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO GENERATION OF TECHNICAL ERRORS RELATED TO THE EVENT. THE LOGS SHOW THAT A SUCCESSFUL SYSTEM CHECK OUT WAS PERFORMED PRIOR TO THE EVENT. WITHOUT ANY ADDITIONAL INFORMATION OR PARTS TO INVESTIGATE, WE ARE UNABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA FAILED TO PROVIDE GAS TO THE PATIENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127433 FLOW-I GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1