BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1874320 · Received October 11, 2010

    Report

    Report Number
    1218950-2010-01904
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THAT PADDLES WERE CONNECTED. THERE WAS NO REPORT OF NEGATIVE PT IMPACT OR INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED ALL STANDARD TESTING AND WAS RETURNED TO SERVICE. WE CANNOT DETERMINE THE CAUSE BECAUSE THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THAT PADDLES WERE CONNECTED. THERE WAS NO REPORT OF NEGATIVE PT IMPACT OR INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1