BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERVIEW

    MDR report key: 14874938 · Received June 30, 2022

    Report

    Report Number
    1000165971-2022-00292
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    April 1, 2022
    Report Date
    August 29, 2022
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MWJ
    PMA / PMN Number
    K032466
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS CONCLUSION IS THE FOLLOWING: THE ANALYSIS OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED ISSUE: NO OVERHEATING WAS REPRODUCED DURING DEVICE TESTS. HOWEVER, THE ANALYSIS CONFIRMED MALFUNCTION OF THE DEVICE AS THE DEVICE CAN HARDLY BE TURNED ON (THEREFORE, NO RECORDING COULD BE LAUNCHED). THE ROOT CAUSE IS MOST PROBABLY AN ELECTRONIC ISSUE AT THE LEVEL OF THE DIGITAL BOARD. THIS CASE IS RECORDED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    REPORTEDLY, AN OVERCONSUMPTION OF THE BATTERY WAS OBSERVED. THE DEVICE OVERHEATS AND SHUTS DOWN QUICKLY. PERFORMING A RESET DID NOT SOLVE THE ISSUE. THE OVERCONSUMPTION WAS CONFIRMED UPON TEST. PRELIMINARY ANALYSIS REVEALED THAT THE OVERCONSUMPTION OBSERVED COULD HAVE LED TO THE REPORTED OVERHEATING.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICE (ITS BATTERY) OVERHEATED AND THE DEVICE SWITCH OFF RAPIDLY. THE RESET DID NOT CORRECT THE PROBLEM. OVERCONSUMPTION OF THE DEVICE WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028615 SPIDERVIEW ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ MWJ SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown