BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 4402853 · Received January 7, 2015

    Report

    Report Number
    3030677-2015-00088
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Report Date
    January 2, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT EVALUTION 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 DIAGNOSITC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11786 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1