BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 2854265 · Received November 27, 2012

    Report

    Report Number
    3030677-2012-01512
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #: M48739113. (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR.

    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
    1 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN NONE MKJ PHILIPS MEDICAL SYSTEMS 861389 M61994-1120

    Patients

    Seq Age Sex Outcome Treatment
    1