BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 2960370 · Received January 25, 2013

    Report

    Report Number
    3030677-2013-00097
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DATE OF MANUFACTURE ON: FEBRUARY 2012. A 510 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
    35255 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN NONE MKJ PHILIPS MEDICAL SYSTEMS 861389 M61994-1120

    Patients

    Seq Age Sex Outcome Treatment
    1