BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3023397 · Received February 26, 2013

    Report

    Report Number
    1218950-2013-00669
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    February 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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). 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 THE EXTERNAL PADDLES IT SEEMS THAT THEY DO NOT HAVE GOOD CONTACT AND THAT THE TEST FAILED. THEY ALSO REPORTED THAT WHEN THEY USE THE TEST LOAD, THEY GET A MAINTENANCE NECESSARY MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83497 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1