BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 1812613 · Received August 18, 2010

    Report

    Report Number
    1218950-2010-01342
    Event Type
    Death
    Date Received
    August 18, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THIS DEFIBRILLATOR WOULD NOT SHOCK WITH EXTERNAL PADDLES. TWO ADDITIONAL DEFIBRILLATORS ((B)(4) AND (B)(4)) WERE USED IN THIS EVENT WITH THE SAME REPORTED SYMPTOM. THE CUSTOMER STATED THAT THE INVOLVED PATIENT MAY HAVE BEEN IMPACTED BECAUSE THEY COULD NOT DELIVER A SHOCK. THE TWO OTHER DEFIBRILLATORS ARE REPORTED SEPARATELY IN MFR REPORT # 1218950-2010-01343 (B)(4) AND IN MFR REPORT # 1218950-2010-01344 (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND THE INVOLVED PADDLE SET AND COULD NOT REPRODUCE THE REPORTED SYMPTOM. IN ADDITION, REVIEW OF THE ECG STRIP SUPPORTS THAT THE DEFIBRILLATOR WAS FUNCTIONING AS DESIGNED. THE DEVICE PASSED ALL STANDARD TESTING AND WAS RETURNED TO SERVICE. ALL AVAILABLE INFORMATION DOES NOT SUPPORT THAT A MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS DEFIBRILLATOR WOULD NOT SHOCK WITH EXTERNAL PADDLES. TWO ADDITIONAL DEFIBRILLATORS ((B)(4) AND (B)(4)) WERE USED IN THIS EVENT WITH THE SAME REPORTED SYMPTOM. THE CUSTOMER STATED THAT THE OUTCOME OF THE INVOLVED PATIENT MAY HAVE BEEN IMPACTED BECAUSE THEY COULD NOT DELIVER A SHOCK. THE TWO OTHER DEFIBRILLATORS ARE REPORTED SEPARATELY IN MFR REPORT # 1218950-2010-01343 (B)(4) AND IN MFR REPORT # 1218950-2010-01344 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death