BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2222365 · Received July 15, 2011

    Report

    Report Number
    1218950-2011-02041
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO POWER ON. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER HAS CHOSEN TO NOT HAVE THE DEVICE EVALUATED/REPAIRED BY PHILIPS. BASED ON THE CUSTOMER'S REPORT WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE FROM THE AVAILABLE INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO POWER ON. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE - ANDOVER M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1