BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 18846750 · Received March 6, 2024

    Report

    Report Number
    0002217809-2024-00010
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    October 21, 2022
    Report Date
    April 24, 2024
    Manufacturer
    SIVANTOS, INC
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT-CAUSE IS A SHORT CIRCUIT DEVELOPED IN THE USB CONNECTOR OR USB RECEPTACLE DUE TO CORROSION, BENT PINS, OR FOREIGN DEBRIS. (RC01, CAR_S-SG_2022_033) CORRECTIVE AND PREVENTATIVE ACTIONS HAVE NOW BEEN IMPLEMENTED IN CASES RELATED TO THERMAL EVENTS IN CHARGER WITH USB C RECEPTACLE AS DOCUMENTED IN CAR_S-SG_2022_033. REDUCED THE PORTABLE CHARGER'S MAXIMUM BATTERY CAPACITY FROM 100% TO 80% TO PREVENT EXTENSIVE BATTERY REACTIONS DURING BATTERY SHORT-CIRCUIT. PREVENTIVE MEASURE HAS BEEN VERIFIED TO BE EFFECTIVE IN FURTHER REDUCING THE POSSIBILITY AND SUFFICIENT ENERGY TO CAUSE SEVERE MELTING CASES. NO FURTHER ROOT CAUSES HAVE BEEN IDENTIFIED; CAPA IS NOW CLOSED. CASE CAN NOW BE CLOSED. WE WERE MADE AWARE, THAT OUR ELECTRONIC SUBMISSIONS FAILED AND NOT RECEIVED BY FDA. A NEW CAPA HAS NOW BEEN OPENED TO ADDRESS THIS ISSUE AND THIS REPORT WAS ELECTRONICALLY RESUBMITTED ON (03/06/2024).

    Description of Event or Problem · 0

    IN THIS EVENT, MELTING OF THE USB CHARGER OCCURED WHILE BEING CHARGED AT THE CHARGER PORT. THERE WAS NO SIGN OF FIRE OR SMOKE RESIDUES. NO INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE INITIAL INVESTIGATION FOUND HEAT DAMAGE NEAR THE USB C CONNECTOR ON THE MAIN PCB, INCL. MELTED PLASTIC AND CRACKED/WARPED PCB.WHITE RESIDUE ON PCB COULD ORIGINATE FROM MOISTURE. INVESTIGATION RESULTS: RESULTS OF CT SCAN SHOWED POSSIBLE SHORT CIRCUIT BETWEEN THE GND AND VBUS PINS ON THE USB TYPE C RECEPTACLE (IN CHARGER). RESULTS FROM TECHNICAL INVESTIGATION (PERFORMED CT IMAGING, X-RAY IMAGING ANALYSIS, MICROSCOPE IMAGING ANALYSIS AND SEM-EDS SPECTROSCOPY ANALYSIS) SHOWS CORROSION IN THE USB RECEPTACLE BETWEEN VBUS AND GND. THE SUSPECTED ROOT CAUSE WAS A SHORT CIRCUIT DEVELOPED IN USB RECEPTACLE DUE TO CORROSION IN THE USB RECEPTACLE BETWEEN VBUS AND GND. THE MEASURED LOW RESISTANCE BETWEEN VBUS AND GND, COMBINED WITH THE CONFIRMED PRESENCE OF CORROSIVE AGENTS IN THE USB RECEPTACLE, CONFIRMS THAT THE ROOT-CAUSE OF THE HEAT DAMAGE WAS DUE TO A SHORT CIRCUIT CAUSED BY THE CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102437 SIGNIA INSIO CHARGER OSM SIVANTOS, INC 10997503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown