BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2123526 · Received June 9, 2011

    Report

    Report Number
    1218950-2011-01637
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THERE WAS NO TROUBLE FOUND WITH THE DEVICE AND NO PARTS WERE REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR DID NOT SHOCK WITH PADDLES DURING A PT EVENT. THERE WAS NO REPORT OF NEGATIVE PT IMPACT.

    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