BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 1712624 · Received June 2, 2010

    Report

    Report Number
    1218950-2010-00836
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 3, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY GOT "NO SHOCK DELIVERED" MESSAGES WHILE ATTEMPTING TO CARDIOVERT A PATIENT. THEY WERE USING EXTERNAL PADDLES AND WERE ATTEMPTING TO DELIVER ENERGY OVER A CLEAR PLASTIC ADHESIVE DRESSING. ONCE THEY REMOVED THE CLEAR PLASTIC DRESSING, THE ENERGY WAS DELIVERED AND CONVERTED THE PATIENT. THE INVOLVED PATIENT SUBSEQUENTLY DIED, BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR. THE PATIENT HAD A VERY COMPLEX CONGENITAL HEART CONDITION AND THE DECISION HAD BEEN MADE TO STOP RESUSCITATION EFFORTS. THE HOSPITAL BIOMEDICAL ENGINEER EVALUATED THE INVOLVED DEFIBRILLATOR AND REPORTED THAT THE DEVICE PASSED ALL TESTING. THE DEVICE WAS PERFORMING TO SPECIFICATIONS. EXTERNAL PADDLES NEED TO BE PLACED DIRECTLY ON THE PATIENT'S CHEST. THIS WAS A USE ISSUE. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY GOT "NO SHOCK DELIVERED" MESSAGES WHILE ATTEMPTING TO CARDIOVERT A PATIENT. THEY WERE USING EXTERNAL PADDLES AND WERE ATTEMPTING TO DELIVER ENERGY OVER A CLEAR PLASTIC ADHESIVE DRESSING. THE INVOLVED PATIENT SUBSEQUENTLY DIED, BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death