BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 2238313 · Received September 1, 2011

    Report

    Report Number
    1218950-2011-02597
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE USER INITIATED SHIFT/SYSTEM CHECK DISPLAYING SYSTEM FAILURE SERVICE UNIT. ON 08/22/2011, THE CUSTOMER CLARIFIED THAT THE DEVICE DISPLAYED ERROR CODE 01000 (DEFIB FAILURE ¿ BIPHASIC PROCESSOR). THE CONDITION PRESENTED DURING USER INITIATED SHIFT/SYSTEM CHECK. THERE WAS NO PT INVOLVEMENT. PHILIPS ADVISED THE CUSTOMER THAT THIS DEVICE HAS BEEN OUT OF SUPPORT LIFE SINCE 12/31/2009, AND THAT NO SERVICE OR REPLACEMENT PARTS ARE AVAILABLE. ON 08/22/2011, THE CUSTOMER REPORTED THAT THE DEVICE HAS BEEN REMOVED FROM SERVICE WITH NO PLANS FOR REPAIR OR RETURN TO SERVICE. BASED ON THE CUSTOMER¿S REPORT, WE WILL CONSIDER THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE FROM THE AVAILABLE INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE USER INITIATED SHIFT/SYSTEM CHECK DISPLAYING SYSTEM FAILURE SERVICE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 4000 MKJ PHILIPS HEALTHCARE - ANDOVER M5500B

    Patients

    Seq Age Sex Outcome Treatment
    1