BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER NEONATAL FLOW SENSOR ISO15

    MDR report key: 11946260 · Received June 4, 2021

    Report

    Report Number
    MW5101714
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 29, 2021
    Report Date
    June 2, 2021
    Product Code
    BXP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRAGER FLOW SENSOR SPARKING WHILE ATTACHED TO PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833114 DRAGER NEONATAL FLOW SENSOR ISO15 TRANSDUCER, GAS FLOW BXP REF 8411130

    Patients

    Seq Age Sex Outcome Treatment
    1