BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM POCKETECG IV

    MDR report key: 23494688 · Received November 7, 2025

    Report

    Report Number
    3007770164-2025-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 7, 2025
    Manufacturer
    MEDICALGORITHMICS S.A
    Product Code
    DSI
    UDI-DI
    05903021560179
    PMA / PMN Number
    K193104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY HAS TAKEN THIS OPPORTUNITY TO REMIND ALL CUSTOMERS TO INSPECT THE BATTERIES PERIODICALLY, PAYING PARTICULAR ATTENTION TO BATTERY LIFETIME AND THE NUMBER OF CHARGING CYCLES. PROPER INSPECTION HELPS ENSURE THE DEVICE FUNCTIONS AS INTENDED AND SAFEGUARDS PATIENT SAFETY. IN ADDITION, THE COMPANY HAS UPDATED THE POCKETECG IV WITH EXPANDED INFORMATION ON HOW TO CHECK THE NUMBER OF CHARGE CYCLES OF THE LI-ION BATTERIES.

    Description of Event or Problem · 0

    REPORT RELATES TO SIMILAR PRODUCT, ADVERS EVENT TOOK PLACE OUTSIDE U.S, WITHIN CANADA. ON AUGUST 19, 2025, THE MANUFACTURER BECAME AWARE THAT POCKETECG IV, TYPE P4TR-CA-ADS DEVICE HAD CAUGHT ON FIRE DURING THE PATIENT EXAMINATION. PATIENT WAS SCHEDULED FOR A 2 DAY HOLTER ON (B)(6) 2025 AT 11:30 AM. AT APPROXIMATELY 4:00 PM ON FRIDAY (B)(6) 2025, PATIENT WAS STANDING IN HIS HOME AND HEARD AN ERUPTION SOUND. THE PATIENT REPORTED THAT HE SAW SPARKS AND FLAMES COMING FROM UNDER HIS SHIRT AND THEN REALIZED THAT IT WAS THE HOLTER THAT HAD CAUGHT ON FIRE. DURING NORMAL USE OF THE PRODUCT, IT SPONTANEOUSLY IGNITED, MOST LIKELY CAUSED BY THE POWER BATTERY, TYPE P4BA-AB-UNI. PATIENT DENIED ANY PHYSICIAN SKIN BURNS ON HIS BODY. HOWEVER, CONFIRMED SENSITIVE PAIN TO THE AREAS EFFECTED BUT AFTER A FEW DAYS HE CONFIRMED THAT NO LONGER FELT THE BURNING SENSATION ON HIS SKIN. BASED ON THE INVESTIGATION AND OBJECTIVE EVIDENCE, NO MANUFACTURING OR DESIGN DEFECT WAS IDENTIFIED IN THE DEVICE OR ITS COMPONENTS. THE ANALYSIS WAS BASED ON OBJECTIVE EVIDENCE, PROCESS REVIEW, AND CONTRIBUTING FACTORS, ENSURING TRACEABILITY AND COMPLIANCE WITH APPLICABLE QUALITY SYSTEM STANDARDS. ALTHOUGH A SINGLE DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, THE INVESTIGATION IDENTIFIED THAT THE BATTERY INVOLVED HAD EXCEEDED ITS RECOMMENDED SERVICE LIFE OF 2 YEARS FROM THE DATE OF MANUFACTURE, AS SPECIFIED IN THE IFU FOR PROFESSIONAL USERS. THIS CONDITION INCREASES THE RISK OF BATTERY OVERHEATING AND POTENTIAL SWELLING OR EXPLOSION, AS THE CAPACITY AND PERFORMANCE OF THE POCKETECG LI-ION BATTERY NATURALLY DEGRADE OVER TIME WITH NORMAL USE. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NONCONFORMITY IS IMPROPER MAINTENANCE AND HANDLING BY THE CUSTOMER, RESULTING FROM USE OF THE BATTERY BEYOND THE RECOMMENDED SERVICE LIFE OF 2 YEARS, CONTRARY TO THE INSTRUCTIONS FOR USE (IFU). BATTERIES USED BEYOND THE SPECIFIED SERVICE PERIOD MAY EXHIBIT REDUCED PERFORMANCE AND INCREASED INTERNAL RESISTANCE, WHICH CAN LEAD TO OVERHEATING OR SWELLING UNDER CERTAIN CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861681 UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM POCKETECG IV DETECTOR AND ALARM, ARRHYTHMIA DSI MEDICALGORITHMICS S.A P4TR-CA-ADS 05903021560179

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other