BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7689911 · Received July 16, 2018

    Report

    Report Number
    3004123209-2018-00451
    Event Type
    Death
    Date Received
    July 16, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 31, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE RESPONDER ALLEGES THAT THE SAM300P WHICH WAS USED IN POSSIBLE CARDIAC EVENT , WITH AN ADULT PAD PAK INSTALLED, ORIGINALLY ISSUED AN ADULT PATIENT VERBAL PROMPT BUT THEN EMITTED A PEDIATRIC VERBAL PROMPT DURING USAGE. THE RESPONDER ALLEGES THAT THIS HAPPENED TWICE DURING USAGE. THE EMT TOOK OVER, HOWEVER THE PATIENT DID NOT SURVIVE. THE RESPONDER STATED THAT THIS UNIT HAD BEEN USED PRIOR WITH NO ISSUES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 20TH APRIL 2011. THE DEVICE PERFORMED TO SPECIFICATION DURING THE REPORTED PATIENT INVOLVED EVENT ON (B)(6) 2018. THE DEVICE WAS POWERED ON AND THE USER WAS ISSUED WITH THE NORMAL ADVISORY SPEECH PROMPTS. DURING THE EVENT, THE PATIENT¿S IMPEDANCE DROPPED OUT OF RANGE. WITH NO IN RANGE IMPEDANCE DETECTED THE USER WAS THEN REPEATEDLY ADVISED TO ¿CHECK PADS, PRESS PADS FIRMLY TO PATIENT¿S BARE SKIN¿. WHEN A STABLE IMPEDANCE WAS DETECTED THE PATIENT¿S HEART RHYTHM WAS ASSESSED AND NO SHOCK WAS ADVISED. THE AUDIO PROMPTS ISSUED FOR THE EVENT WERE REVIEWED AGAINST THOSE STATED WITHIN THE USER MANUAL AND ALL WERE CONSISTENT WITH USE WITH AN ADULT PAD-PAK. THE DEVICES ABILITY TO SUCCESSFULLY DETECT AND RECORD THE ADULT AND CHILD PATIENT PROMPTS WAS VERIFIED DURING THE INVESTIGATION. THE DEVICE WAS ALSO FOUND TO BE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE RANGE, EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. THE SW1 REED SWITCH IS THE MECHANISM BY WHICH THE DEVICE DETECTS THAT A PEDI-PAK HAS BEEN INSTALLED AND THEREFORE WILL ISSUE THE CHILD PATIENT PROMPT. THE REED SWITCH WAS VERIFIED DURING THE INVESTIGATION AND ALSO AFTER THE DEVICE HAD BEEN SUBJECTED TO STRESS TESTING, WITH NO FAULT FOUND. THE LABELLING REVIEW IDENTIFIED THAT THE SPEECH PROMPTS ISSUED FOR CHILD PATIENT AND ADULT PATIENT ARE IDENTICAL AFTER THE INITIAL PROMPT. NEITHER THE PAEDIATRIC OR ADULT ICON ON THE USER INTERFACE LIGHT UP. THIS IS NOT A FEATURE ON THIS DEVICE AND NO LED IS IN CLOSE VICINITY OF THESE ICONS. THE INVESTIGATION WAS THEREFORE UNABLE TO CONFIRM THE REPORTED FAULT. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE RESPONDER ALLEGES THAT THE SAM300P WHICH WAS USED IN POSSIBLE CARDIAC EVENT , WITH AN ADULT PAD PAK INSTALLED, ORIGINALLY ISSUED AN ADULT PATIENT VERBAL PROMPT BUT THEN EMITTED A PEDIATRIC VERBAL PROMPT DURING USAGE. THE RESPONDER ALLEGES THAT THIS HAPPENED TWICE DURING USAGE. THE EMT TOOK OVER,HOWEVER THE PATIENT DID NOT SURVIVE. THE RESPONDER STATED THAT THIS UNIT HAD BEEN USED PRIOR WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531918 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death