BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2894300 · Received November 16, 2012

    Report

    Report Number
    1218950-2012-03801
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED SYMPTOM IS AN ALARMS EKG LEADS MALFUNCTION. THE PHILIPS AND OVER BENCH CONFIRMED A FAILURE ON ECG LEAD V1. THERE WAS NO DEATH OR SERIOUS INJURY TO THE PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTED SYMPTOM IS AN ALARMS EKG LEADS MALFUNCTION. THE PHILIPS AND OVER BENCH CONFIRMED A FAILURE ON ECG LEAD V1. THERE WAS NO DEATH OR SERIOUS INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1