BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2019-030774

    MDR report key: 8471749 · Received April 1, 2019

    Report

    Report Number
    3004753838-2019-030774
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 1, 2019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR