BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060122 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00963
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE V5 WAVEFORM WAS NOT BEING DISPLAYED. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM WAS REPRODUCED. THE ISSUE WAS LOCALIZED TO THE ECG CONNECTOR. THE ECG CONNECTOR WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THE ECG CONNECTOR CAUSED THE V5 WAVEFORM MALFUNCTION. REPLACEMENT OF THE CONNECTOR RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE V5 WAVEFORM WAS NOT BEING DISPLAYED. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114969 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1