BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 1901521 · Received November 9, 2010

    Report

    Report Number
    1218950-2010-02186
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT AFTER STARTING THE MACHINE, THE DEFIBRILLATOR FUNCTION CAN'T BE USED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER STARTING THE MACHINE, THE DEFIBRILLATOR FUNCTION CAN'T BE USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1