BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 2023154 · Received February 15, 2011

    Report

    Report Number
    3030677-2011-00033
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INTERNAL MEMORY AND ECG WERE REVIEWED FOR THIS INCIDENT. CONCLUSION: CUSTOMER REPORTED THAT THE DEVICE OPERATED PROPERLY.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, THE SUBJECT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3861A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death