BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART XL

    MDR report key: 3052573 · Received April 5, 2013

    Report

    Report Number
    1218950-2013-01248
    Event Type
    Death
    Date Received
    April 5, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(6) SUBMITTED A REPORT TO PHILIPS ON BEHALF OF THE CUSTOMER WHICH STATED THAT DURING A CARDIAC ARREST, THE DEFIBRILLATOR WAS SET TO 2 JOULES INSTEAD OF 150 JOULES FOR THE FIRST SHOCK. THE USERS CORRECTED THE JOULE SETTING AND THE RESUSCITATION EFFORT CONTINUED. THE INVOLVED PT ULTIMATELY DIED. NO SPECIFIC ALLEGATION IS UNDERSTOOD AT THIS TIME AND IT IS UNK WHETHER THE CUSTOMER BELIEVES THAT DEATH WAS RELATED IN ANY WAY TO THE SELECTION OF ENERGY FOR THE FIRST SHOCK. WE HAVE REQUESTED ADDITIONAL INFORMATION. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE (B)(6) SUBMITTED A REPORT TO PHILIPS ON BEHALF OF THE CUSTOMER WHICH STATED THAT DURING A CARDIAC ARREST, THE DEFIBRILLATOR WAS SET TO 2 JOULES INSTEAD OF 150 JOULES FOR THE FIRST SHOCK. THE USERS CORRECTED THE JOULE SETTING AND THE RESUSCITATION EFFORT CONTINUED. THE INVOLVED PT ULTIMATELY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139973 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death