BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3043366 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00828
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A PHILIPS FSE WENT ON SITE TO EVALUATE THE DEVICE AT THE CUSTOMERS REQUEST. DURING THE DEVICE EVALUATION THE FSE WAS INFORMED OF A FAILURE TO DISCHARGE IN AED MODE DURING USE ON (B)(4) 2012. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE SYMPTOM COULD NOT BE DUPLICATED. NO EVENT SUMMARY/STRIPS WERE AVAILABLE FOR REVIEW. THE DEVICE PASSED ALL REQUIRED TESTING AND WAS RETURNED TO SERVICE AT THE CUSTOMER SITE. BASED ON THE CUSTOMER'S REPORT WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    A PHILIPS FSE WENT ON SITE TO EVALUATE THE DEVICE AT THE CUSTOMERS REQUEST. DURING THE DEVICE EVALUATION THE FSE WAS INFORMED OF A FAILURE TO DISCHARGE IN AED MODE DURING USE ON (B)(4) 2012. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102541 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1