BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3100029 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01458
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BIOMED WAS NOT ABLE TO REPRODUCE THE TEST FAILURE, AND COULD PROVIDE NO ADDITIONAL INFORMATION. THE BIOMED TOOK THE DEVICE OUT OF SERVICE. NO ADDITIONAL ACTION WAS REQUESTED FROM PHILIPS. THE BIOMED NOTED THAT HE CALLED PHILIPS TO ADVISE THEM OF THE TEST FAILURE ONLY. THE CAUSE OF THE TEST FAILURE IS UNKNOWN. WE ARE CONSIDERING THIS A MALFUNCTION BUT WE ARE UNABLE TO DETERMINE THE CAUSE BECAUSE THE SYMPTOM WAS NOT REPRODUCED BY THE CUSTOMER, AND THE DEVICE WAS NOT EVALUATED BY PHILIPS.

    Description of Event or Problem · 1

    THE BIOMED CALLED TO REPORT THAT THE USER HAD REPORTED TO HIM THAT THE DEVICE HAD FAILED THE PADDLES TEST IN SHIFT CHECK. THIS OCCURRED DURING TESTING; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182233 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1