BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOBILEDIAGNOST WDR REL. 2

    MDR report key: 8232632 · Received January 9, 2019

    Report

    Report Number
    1217116-2019-00001
    Event Type
    Death
    Date Received
    January 9, 2019
    Date of Event
    December 14, 2018
    Report Date
    December 14, 2018
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER (HOSPITAL) REPORTED DEATH OF NEONATAL BABY WHICH THEY ALLEGE IS DUE TO POOR IMAGING OF TUBES AND LINES, RESULTING IN LINE TOUCHING HEART AND CAUSING AF UNTIL DEATH OCCURRED. CUSTOMER ALLEGED THAT IMAGE WAS NOT GOOD ENOUGH QUALITY TO SEE TIP OF LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23409 MOBILEDIAGNOST WDR REL. 2 SYSTEM, X RAY, MOBILE IZL 712002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death