BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 8817802 · Received July 23, 2019

    Report

    Report Number
    1218950-2019-05404
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    July 1, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE REBOOTS WHEN THE CHARGE BUTTON IS PRESSED. THERE WAS NO PATIENT INVOLVEMENT. THE BATTERY PCA WAS RETURNED TO THE FAILURE ANALYSIS (FA) LAB FOR EVALUATION. THE BATTERY PCA WAS VISUALLY INSPECTED FOR ANY MECHANICAL DAMAGE AND/OR CONTAMINATION, AND NO ANOMALIES WERE FOUND. ALL SPRING-LOADED POGO-PINS (ON CONNECTOR J1 AND J2) AND SINGLE POWER CONTACT PINS (ON CONNECTOR J3 THROUGH J7) WERE FOUND TO BE IN NORMAL SHAPE AND CONDITION. REPORTED PROBLEM WAS NOT VERIFIED DURING VISUAL INSPECTION ¿ NO FAULT FOUND - NFF.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE REBOOTS WHEN THE CHARGE BUTTON IS PRESSED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609400 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1