BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8366330 · Received February 25, 2019

    Report

    Report Number
    3004123209-2019-00087
    Event Type
    Death
    Date Received
    February 25, 2019
    Date of Event
    February 16, 2019
    Report Date
    August 1, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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).

    Additional Manufacturer Narrative · 0

    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.. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2011. THE DEVICE RECORDED NO MANUAL POWER ONS ON THE DATE OF THE REPORTED PATIENT-INVOLVED EVENT ON THE (B)(6) 2019. ONE AUTO SELF-TEST PASS WAS RECORDED AT 10.11H(GMT) ON THIS DATE WHICH WOULD INDICATE A PAD-PAK HAD NOT BEEN INSTALLED SINCE THE PREVIOUS LOG ENTRY ON THE (B)(6) 2019. INFORMATION FROM THE DEVICE MEMORY REVEALED THE DEVICE HAD DELIVERED MULTIPLE SHOCKS DURING PATIENT-INVOLVED EVENTS THROUGHOUT ITS TIME IN SERVICE. THE DEVICE MEMORY HAD THEREFORE BECOME FULL BY THE (B)(6) 2015, MORE THAN 3 YEARS PRIOR TO THE REPORTED EVENT. A ¿MEMORY FULL¿ PROMPT WOULD THEREFORE HAVE BEEN ISSUED TO THE USER DURING AUTO SELF-TEST ON THE DATE OF THE REPORTED EVENT. AS PER THE LABELLING REVIEW, THIS ISSUE WOULD NOT HAVE IMPACTED THE DEVICE¿S ABILITY TO ANALYSE OR PERFORM SHOCK THERAPY. DURING INVESTIGATION, THE DEVICE CORRECTLY ANALYSED A PATIENT RHYTHM MULTIPLE TIMES AND DELIVERED THE FULL SHOCK THERAPY SEQUENCE WITHOUT FAULT. THE DEVICE WAS CONFIRMED TO RECORD ECG DATA ACCURATELY WITHOUT NOISE OR OTHER ABNORMALITIES. THE DEVICE PERFORMED TO SPECIFICATION. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    A 300P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE ANY ANALYSIS WHEN CONNECTED TO THE PATIENT. A SECOND DEVICE WAS USED AT THE SCENE AND IT REPORTEDLY HAD THE SAME ISSUE. CPR WAS PERFORMED ON THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    A 300P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE ANY ANALYSIS WHEN CONNECTED TO THE PATIENT. A SECOND DEVICE WAS USED AT THE SCENE AND IT REPORTEDLY HAD THE SAME ISSUE. CPR WAS PERFORMED ON THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161331 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1