BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 8185545 · Received December 20, 2018

    Report

    Report Number
    8010042-2018-00692
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 27, 2018
    Report Date
    March 15, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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). THE ANESTHESIA WORKSTATION WAS EXAMINED BY THE HOSPITAL TECHNICIANS WITHOUT BEING ABLE TO REPRODUCE THE ISSUES. NO INFORMATION HAS BEEN PROVIDED WHETHER ANY PARTS HAVE BEEN REPLACED OR IF THE REPORTED ISSUE HAS RECURRED SINCE. DEVICE LOGS HAVE BEEN RECEIVED AND THE REPORTED ISSUE WITH A HIGH FICO2 LEVEL DESPITE HAVING CHANGED THE CO2 ABSORBER CAN BE CONFIRMED. THE CLINICAL ALARMS THAT WERE GENERATED SHOW THAT HIGH FICO2 VALUES WERE MEASURED BUT WITHOUT HAVING RECEIVED ANY ADDITIONAL INFORMATION SURROUNDING THE EVENT SUCH AS REPLACED PARTS, WE CANNOT DETERMINE THE CAUSE OF THE REPORTED INCREASED LEVEL OF FICO2 VALUES.

    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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION MEASURED A HIGHER FICO2 LEVEL THAN EXPECTED DURING AN EXTENDED TIME PERIOD. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023497 FLOW-I C30 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C30

    Patients

    Seq Age Sex Outcome Treatment
    1