BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1854347 · Received September 29, 2010

    Report

    Report Number
    1218950-2010-01751
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    August 31, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED HAVING PROBLEMS WITH THE PACING FUNCTION OF THE DEVICE. THERE WAS NO REPORT OF PT IMPACT OR INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING PROBLEMS WITH THE PACING FUNCTION OF THE DEVICE. THERE WAS NO REPORT OF PATIENT 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