BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 4736613 · Received April 27, 2015

    Report

    Report Number
    3030677-2015-01051
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Report Date
    April 10, 2015
    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).

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR. 510(K): K111693.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DEVICE VOICE PROMPTS ARE NOT FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276397 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN AED MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1