BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2427849 · Received January 19, 2012

    Report

    Report Number
    1218950-2012-00175
    Event Type
    Death
    Date Received
    January 19, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED A DEVICE FAILURE WHILE PACING A BRADYCARDIC PATIENT. REVIEW OF THE EVENT FILE SHOWED THAT THE USERS HAD DIFFICULTY ESTABLISHING A LEADS ECG WAVEFORM IN ORDER TO DEMAND MODE PACE THE PATIENT. THE USERS DID TROUBLESHOOTING AND WERE ABLE TO RESOLVED THE ISSUE AND CONTINUE CARE OF THE PATIENT. THE INVOLVED PATIENT DIED BUT IT HAS NOT YET BEEN REPORTED WHETHER THE DEVICE BEHAVIOR IMPACTED THE PATIENT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A DEVICE FAILURE WHILE PACING A BRADYCARDIC PATIENT. REVIEW OF THE EVENT FILE SHOWED THAT THE USERS HAD DIFFICULTY ESTABLISHING A LEADS ECG WAVEFORM IN ORDER TO DEMAND MODE PACE THE PATIENT. THE USERS DID TROUBLESHOOTING AND WERE ABLE TO RESOLVED THE ISSUE AND CONTINUE CARE OF THE PATIENT. THE INVOLVED PATIENT DIED BUT IT HAS NOT YET BEEN REPORTED WHETHER THE DEVICE BEHAVIOR IMPACTED THE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death