BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-I C20

    MDR report key: 7556613 · Received May 31, 2018

    Report

    Report Number
    8010042-2018-00270
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    March 30, 2018
    Report Date
    May 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K160665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH (MW5077032) WAS RECEIVED STATING THAT "ETCO2 WATER TRAP LINE BECAME DISLODGED DURING AIRWAY MANAGEMENT DURING A SURGICAL PROCEDURE." THE EVENT REPORT TYPE IS SET TO SERIOUS INJURY. APART FROM THE RECEIVED PROBLEM DESCRIPTION STATED IN THE MEDWATCH REPORT, WE HAVE NOT RECEIVED ANY INFORMATION SUCH AS DEVICE SERIAL NUMBER, DEVICE LOGS, DEFECTIVE/REPLACED PARTS OR HOSPITAL INFORMATION. NO INFORMATION REGARDING MEDICAL INTERVENTION HAS BEEN RECEIVED. WITH THE INFORMATION GIVEN, WE ARE UNABLE TO DRAW ANY CONCLUSIONS AND TO DETERMINE ANY ROOT-CAUSE OF THE REPORTED EVENT. 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

    IT WAS REPORTED THAT THE ETCO2 WATER TRAP LINE BECAME DISLODGED DURING AIRWAY MANAGEMENT DURING A SURGICAL PROCEDURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401568 FLOW-I C20 VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other