BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 4096158 · Received August 29, 2014

    Report

    Report Number
    3030677-2014-01988
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Report Date
    August 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR. SERIAL NUMBER UNKNOWN. SERIAL NUMBER WILL BE REPORTED AT TIME OF FOLLOW UP. A 510(K) K111693.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528663 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1