BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1980155 · Received January 31, 2011

    Report

    Report Number
    3030677-2011-00005
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 17, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: DEVICE INTERNAL MEMORY AND ECG WERE REVIEWED FOR THIS INCIDENT. CONCLUSION: ECG ARTIFACT CONSISTENT WITH CPR, UNDERLINING RHYTHM WAS CONSISTENT WITH ASYSTOLE. CORRECTION: DATE OF THIS REPORT IS (B)(6) 2011 AND DATE OF EVENT IS (B)(6) 2010.

    Description of Event or Problem · 1

    SUBJECT WAS NOT RESUSCITATED, PHYSICIAN QUESTIONED RELATED ECG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death