BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2230965 · Received July 21, 2011

    Report

    Report Number
    1218950-2011-02101
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS AN INTERMITTENT PADS CONNECTION DURING TESTING. THERE WAS NO PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND COULD NOT REPRODUCE THE REPORTED SYMPTOM. MULTIPLE PARTS WERE REPLACED AT THE DISCRETION OF REPAIR PERSONNEL AND FOR CUSTOMER SATISFACTION. THE DEVICE PASSED ALL STANDARD TESTING AND WAS RETURNED TO SERVICE. WE ARE CONSIDERING THIS A MALFUNCTION BASED ON THE CUSTOMER'S REPORT ONLY. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN INTERMITTENT CONNECTION DURING TESTING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1