BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 3060311 · Received April 11, 2013

    Report

    Report Number
    3030677-2013-00571
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    April 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON AGE OF DEVICE - CUSTOMER HAS BEEN ADVISED TO REMOVE FROM SERVICE. REPORTED AS ALERT COULD NOT BE CLEARED BY USER.

    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
    154305 HEARTSTART ONSITE MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1