BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2842094 · Received November 16, 2012

    Report

    Report Number
    3004123209-2012-00215
    Event Type
    Death
    Date Received
    November 16, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 13, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED ON (B)(6) 2012 AT 9:00AM. THE RETURNED DEVICE HAD PREVIOUSLY BEEN USED IN (B)(6) 2008 IN AN EVENT WHICH LASTED FOR 22 MINUTES. DURING THIS EVENT, 4 SHOCKS WERE DELIVERED. WE HAVE NO FURTHER INFO ON THIS EVENT SO WE MUST ASSUME THAT THE DEVICE PERFORMED AS EXPECTED. THE DEVICE WAS USED AGAIN IN (B)(6) 2008 IN AN EVENT WHICH LASTED 11 MINUTES. ON THIS OCCASION NO SHOCKABLE RHYTHM WAS DETECTED AND NO SHOCKS WERE DELIVERED. AGAIN WE HAVE NO FURTHER INFO ON THIS EVENT. THE DEVICE IS USED AGAIN IN (B)(6) 2012 IN AN EVENT WHICH LASTED FOR JUST 2 MINUTES. DURING THIS EVENT A "NON SHOCKABLE" RHYTHM WAS DETECTED AND NO SHOCK WAS ADVISED. DURING THIS EVENT THE MEMORY IN THE DEVICE BECAME FULL AND THE USER WAS ALERTED TO THIS FACT WHEN THE DEVICE WAS SHUT DOWN AT THE END OF THE EVENT. AS A RESULT OF THE MEMORY BECOMING FULL IN (B)(6) 2012, THE EVENT ECG TRACE FROM (B)(6) 2012 COULD NOT BE DOWNLOADED. HOWEVER THE SEQUENCE OF PROMPTS ISSUED BY THE DEVICE WAS RETRIEVED. THE EVENT LASTED FOR 1 MINUTE AND 13 SECONDS. THE DEVICE ISSUED A WARNING THAT THE MEMORY WAS FULL. IT ANALYZED THE PT'S HEART RHYTHM, ADVISED A SHOCK AND A SHOCK WAS DELIVERED. THE DEVICE THEN ADVISED CPR TO COMMENCE BUT SHUT ITSELF DOWN. THE RETURNED PAD DEVICE AND PAD-PAK WERE THOROUGHLY TESTED IN HEARTSINE TECHNOLOGIES, BELFAST BUT NO FAULT COULD BE FOUND WITH EITHER THE PAD DEVICE OR PAD-PAK. TESTING AT ROOM TEMP CONFIRMED THAT THE RETURNED PAD DEVICE AND PAD-PAK WERE CAPABLE OF DELIVERING MORE THAN 20 SHOCKS. THE DEVICE DID ISSUE LOW BATTERY WARNINGS DURING THE TESTING BUT IT DID NOT SWITCH ITSELF OFF AT ANY TIME. WHEN TESTING WAS CARRIED OUT AT A LOWER TEMP (5 DEGREES CELSIUS) THE REPORTED PROBLEM WAS REPLICATED - THE DEVICE DELIVERED A SHOCK, ISSUED A LOW BATTERY WARNING AND SHUT ITSELF DOWN. THE CONCLUSION TO THE INVESTIGATION WAS THAT NO FAULT WAS FOUND WITH EITHER THE RETURNED PAD DEVICE OR PAD-PAK. THE REPORTED PROBLEM COULD ONLY BE REPLICATED WHEN BOTH THE DEVICE AND PAD-PAK WERE LOWERED TO A TEMP OF 5 DEGREES CELSIUS. IT IS CONSIDERED LIKELY THEREFORE THAT THE DEVICE WAS STORED OR USED IN AN ENVIRONMENT WHERE LOW TEMPS WERE PRESENT. THE WEATHER AT THE LOCATION OF THE EVENT ON THE DATE OF USE WAS CHECKED USING THE ONLINE WEATHER SITE OF THE (B)(4). THIS CONFIRMED A LOW OF 4 DEGREES CELSIUS AND A HIGH OF 13 DEGREES CELSIUS ON THE DAY. HEARTSINE TECHNOLOGIES ARE CURRENTLY UNDERTAKING A VOLUNTARY RECALL, REF Z-0124-2013. WE HAVE INVESTIGATED THIS COMPLAINT/EVENT THOROUGHLY BUT WE HAVE NOT BEEN ABLE TO RULE OUT THE POSSIBILITY THAT THE EVENT MAY BE RELATED TO THE BATTERY MGMT ISSUE WHICH IS CURRENTLY BEING DEALT WITH THROUGH THIS RECALL.

    Description of Event or Problem · 1

    THIS DEVICE WAS USED IN A SUDDEN CARDIAC ARREST OF A (B)(6) FEMALE PT, IN WHICH THE PT DID NOT SURVIVE. THE RESPONDER WAS NOTIFIED ABOUT THE INCIDENT AND ARRIVED AT THE PT'S HOME APPROXIMATELY 15 MINUTES AFTER HAVING BEEN ALERTED. CPR WAS IN PROGRESS. THE AED ELECTRODE PADS WERE ATTACHED TO THE PT AND A SHOCK WAS ADVISED AND DELIVERED. THE DEVICE ISSUED "LOW BATTERY" AND "MEMORY FULL" MESSAGES AND APPEARED TO SHUT DOWN. NO OTHER INFO WAS PROVIDED BY THE PAD DEVICE AFTER THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death