BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POCKETECG V3 - MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

    MDR report key: 5070181 · Received September 9, 2015

    Report

    Report Number
    3007770164-2015-00001
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MEDICALGORITHMICS S.A.
    Product Code
    DSI
    PMA / PMN Number
    K124060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR HAS RETURNED TO THE MANUFACTURER ONE SWOLLEN LI-ON 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 IS REQUIRED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595207 POCKETECG V3 - MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM DETECTOR AND ALARM, ARRHYTHMIA DSI MEDICALGORITHMICS S.A. POCKETECG V3

    Patients

    Seq Age Sex Outcome Treatment
    1