BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POCKETECG V3 - MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

    MDR report key: 7395047 · Received April 4, 2018

    Report

    Report Number
    3007770164-2018-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    July 29, 2015
    Report Date
    April 4, 2018
    Manufacturer
    MEDICALGORITHMICS S.A.
    Product Code
    DSI
    PMA / PMN Number
    K1214060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERIM CONTAINMENT ACTIONS: PRELIMINARY INSPECTION OF THE SUBJECT BATTERY AND VERIFICATION OF THE TRACEABILITY DATA FROM THE MANUFACTURING PROCESS. DATA DID NOT INDICATE POTENTIAL ROOT CAUSE OF THE PROBLEM. INSPECTION AND FUNCTIONAL TEST OF THE POCKETECG TRANSMITTER (TYPE: PECGT-III, S/N: (B)(6)) AND POCKETECG BATTERY CHARGER (TYPE: PECGC-III, S/N: (B)(6)) BEING IN SERVICE WITH THE SUBJECT BATTERY, HAD BEEN PERFORMED. BOTH DEVICES WERE FOUND TO WORK PROPERLY. VERIFICATION OF BATTERY DESIGN. 55 SAMPLES OF THE COMPLETE BATTERY AND BATTERY CELLS WILL BE SUBJECTED FOR TESTS ACCORDING TO TEST PROGRAM DESCRIBED IN LABORATORY DATA PACKAGE 150804_SWOLLEN_BATTERY_P3. ALL TESTS WERE COMPLETED WITH POSITIVE RESULT

    Description of Event or Problem · 0

    THE DISTRIBUTOR HAS RETURNED TO THE MANUFACTURER ONE SWOLLEN LI-ION BATTERY WITH FOLLOWING INFORMATION: ONE OF THE DISTRIBUTOR'S EMPLOYEE KEPT THE BATTERY AND CHARGER IN HIS OFFICE. AFTER CERTAIN AMOUNT OF TIME HE NOTICED THAT THE BATTERY IS SWOLLEN. THE DISTRIBUTOR NEVER REPORTED THE PROBLEM WITH SUBJECT BATTERY BEFORE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT IMPACT. THE BATTERY WAS MANUFACTURED IN JUNE 2014 AND INITIAL VERIFICATION OF THE TRACEABILITY DATA FROM THE MANUFACTURING PROCESS DOES NOT INDICATE POTENTIAL ROOT CAUSE OF THE PROBLEM. FURTHER ANALYSIS HAS BEEN DESCRIBED IN SECTION H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241113 POCKETECG V3 - MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM DETECTOR AND ALARM, ARRHYTHMIA DSI MEDICALGORITHMICS S.A. POCKETECG V3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other