BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3061657 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01102
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING TESTING. THIS OCCURRED DURING TESTING; THERE WAS NO PT INVOLVEMENT. THE CALL CENTER REPRESENTATIVE AND THE CUSTOMER PERFORMED TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE THE PADDLE SET. THE CUSTOMER WAS ADVISED TO REPLACE THE PADDLE SET. THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS ISSUE. BASED ON THE AVAILABLE INFORMATION, WE ARE CONSIDERING THIS A MALFUNCTION OF THE EXTERNAL PADDLE SET. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING TESTING. THIS OCCURRED DURING TESTING; THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129202 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1