BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR 3 ECG BASIC BUNDLE EUROPE

    MDR report key: 4260819 · Received November 14, 2014

    Report

    Report Number
    3030677-2014-02668
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED IS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738859 HEARTSTART FR 3 ECG BASIC BUNDLE EUROPE MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1