BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 3150113 · Received June 3, 2013

    Report

    Report Number
    3030677-2013-00891
    Event Type
    Other
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ECG WAS REVIEWED FOR THIS PT USE EVENT. CONCLUSION: THE ECG WAS REVIEWED AND IT WAS DETERMINED THAT THE PT HAD A BORDERLINE SHOCKABLE RHYTHM. THE DEVICE HAD ADVISED NO SHOCK BUT DUE TO A SLIGHT CHANGE IN THE HEART RATE, THE DEVICE CHANGE IT'S SHOCK DECISION AND ADVISED A SHOCK.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF A DEVICE, THE USER QUESTIONED THE SHOCK DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242738 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN NONE MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1