BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3063353 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01075
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A THERAPY KNOB FAILURE ERROR MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS NOT REPRODUCED OR CONFIRMED. THERE WAS NOT TROUBLE FOUND WITH THE DEVICE. THE BENCH TECH ELECTED TO RELOAD THE SOFTWARE ON THE DEVICE AND RESEAT ALL THE CONNECTIONS FOR PREVENTATIVE MAINTENANCE. THE DEVICE PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER. THE TRENDING DATA DOES NOT SUPPORT THAT THERE IS SYSTEMIC PROBLEM OR EMERGING ISSUE INVOLVING THE SYMPTOM(S) AND FAILURE ASSOCIATED WITH THIS COMPLAINT. WE ARE CONSIDERING THIS A MALFUNCTION. WE ARE UNABLE TO DETERMINE THE CAUSE AS THE REPORTED SYMPTOM WAS NOT CONFIRMED OR REPORTED WHEN THE DEVICE WAS EVALUATED AT PHILIPS. THERE WAS NO TROUBLE FOUND WITH THE DEVICE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A THERAPY KNOB FAILURE ERROR MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127138 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1