BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 2820673 · Received November 2, 2012

    Report

    Report Number
    3030677-2012-01438
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    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 ONSITE MKJ PHILIPS MEDICAL SYSTEMS M5066

    Patients

    Seq Age Sex Outcome Treatment
    1