BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS FR2 INFANT/CHIL DEFIBRILATION PADS

    MDR report key: 462505 · Received May 23, 2003

    Report

    Report Number
    3030677-2003-00048
    Event Type
    Malfunction
    Date Received
    May 23, 2003
    Report Date
    April 24, 2003
    Manufacturer
    PHILIPS MEDICAL SYSTEMS HEARTSTREAM
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT SUFFERED FROM CARDIAC ARREST. A PAIR OF FR2 INFANT/CHILD PADS WERE CONNECTED TO A FR2 DEFIBRILLATOR BY THE AMBULANCE PERSONNEL BUT THE DEFIBRILLATOR COULD NOT ANALYZE THE RHYTHM BECAUSE OF INSUFFICIENT CONTACT BETWEEN PADS AND PATIENT'S SKIN. THE PATIENT'S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS FR2 INFANT/CHIL DEFIBRILATION PADS EXTERNAL DEFIBRILLATION PADS MKJ PHILIPS MEDICAL SYSTEMS HEARTSTREAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Other