BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTVIEW HOTSPOT

    MDR report key: 6966938 · Received October 20, 2017

    Report

    Report Number
    1000165971-2017-00780
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 21, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED REPORT.

    Description of Event or Problem · 1

    A PHONE CALL WAS REPORTED BY A NURSE DURING A FOLLOW UP. AN ORANGE DIODE WAS SHOWN AND THEN THE BUTTON MOVED DIRECTLY TO RED. THREE ATTEMPTS WERE PERFORMED TO RECONNECT THE SYSTEM BUT THE SYMPTOM REMAINED UNCHANGED. THE UNIT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    A PHONE CALL WAS REPORTED BY A NURSE DURING A FOLLOW UP. AN ORANGE DIODE WAS SHOWN AND THEN THE BUTTON MOVED DIRECTLY TO RED. THREE ATTEMPTS WERE PERFORMED TO RECONNECT THE SYSTEM BUT THE SYMPTOM REMAINED UNCHANGED. THE UNIT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745629 SMARTVIEW HOTSPOT UNKNOWN MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW HOTSPOT GPRS

    Patients

    Seq Age Sex Outcome Treatment
    1