BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 3884320 · Received May 14, 2014

    Report

    Report Number
    8010042-2014-00218
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K112114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN INVESTIGATION IS FINISHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA WORKSTATION GENERATED AN ALARM FOR LOWER OXYGEN CONCENTRATION THAN SET. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288191 FLOW-I C30 BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1