BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX

    MDR report key: 1743457 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00184
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    May 5, 2009
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM (ASYSTOLE), NO SHOCK WAS ADVISED/NO SHOCK WAS DELIVERED. DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME.

    Description of Event or Problem · 1

    USERS REPORTED THAT FRX DID NOT RECOMMEND AND DID NOT PROVIDE ANY SHOCK WHEN PLACED ON A PT. PT SHOWED A CARDIO-PULMONARY ARREST, BUT HIS RHYTHM WAS NOT A VFIB. BUT AN ASYSTOLE. IT WAS CONFIRMED BY THE CLINICIANS AFTER THE INCIDENT THAT AEDS ARE ONLY ADDRESSING VENTRICULAR RHYTHM ISSUES SUCH AS VF, VFLUTTER. NEVERTHELESS THEY CLAIMED THIS WAS NOT MADE CLEAR TO USERS DURING PRODUCT INSTALLATION. (B) (4) FROM (B) (4). (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRX AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM 989803138241

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death