BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3192496 · Received June 19, 2013

    Report

    Report Number
    1218950-2013-02502
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    May 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DURING ANNUAL PERFORMANCE MAINTENANCE THEY DISCOVERED THE DEVICE DID NOT DETECTED THE PADDLES. NO PT INVOLVEMENT HAS BEEN STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279226 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1