BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2467770 · Received February 16, 2012

    Report

    Report Number
    3030677-2012-00071
    Event Type
    Other
    Date Received
    February 16, 2012
    Report Date
    January 25, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: THE AED ADVISED NO SHOCK ON A NON-SHOCKABLE RHYTHM.

    Description of Event or Problem · 1

    DURING DEPLOYMENT THE USER REPORTED THAT THE DEVICE DID NOT SHOCK A SHOCKABLE RHYTHM.

    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 44 YR