BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERVIEW

    MDR report key: 10828380 · Received November 12, 2020

    Report

    Report Number
    1000165971-2020-00704
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 21, 2020
    Report Date
    April 30, 2021
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MWJ
    PMA / PMN Number
    K032466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, THE SUBJECT DEVICE AND THE BATTERY BECAME HOT.

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT DEVICE AND THE BATTERY BECAME HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295485 SPIDERVIEW ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW

    Patients

    Seq Age Sex Outcome Treatment
    1