BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 3868711 · Received May 7, 2014

    Report

    Report Number
    8010042-2014-00206
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K112114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT USING INFANT SETTINGS, THE USER DECIDED TO GO TO A STANDBY TO PAUSE THE VENTILATION. WHEN THE STANDBY BUTTON IS PRESSED, TWO CHOICES ARE GIVEN ON THE SCREEN. 1. GO TO STANDBY AND 2. GO TO STANDBY AND RETURN TO STARTUP CONFIGURATION. IN THIS CASE THE USER CHOSE ALTERNATIVE 2. THE START UP CONFIGURATION ON THIS MACHINE WAS PRESET TO ADULT PATIENT CATEGORY AND PRVC MODE. WHEN RESUMING THE VENTILATION AGAIN, THE USER DID NOT NOTICE THAT THE PATIENT CATEGORY AND SETTINGS CHANGE WAS PERFORMED WHEN ACCEPTING ALTERNATIVE 2. AS A CONSEQUENCE OF THE USER ACTION, THE PATIENT WAS EXPOSED TO A LARGER VOLUME AND HIGHER PRESSURE THAN INTENDED, FOR ONE OR TWO BREATHS. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275553 FLOW-I C30 BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1