BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1914029 · Received November 19, 2010

    Report

    Report Number
    1218950-2010-02319
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 22, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PACER TEST. THERE WAS NO REPORT OF PATIENT IMPACT OR INVOLVEMENT. THE CUSTOMER EVALUATED THE DEVICE WITH THE SUPPORT OF PHILIPS CUSTOMER SERVICE CENTER. NO PARTS WERE ORDERED AND NO ROOT CAUSE WAS IDENTIFIED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. WE CANNOT DETERMINE THE CAUSES AS THE SYMPTOM COULD NOT BE DUPLICATED. AS OF (B)(4)THERE HAS BEEN NO FURTHER REPORTS FROM THIS CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PACER TEST. 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 AGILENT TECHNOLOGIES, INC. M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1