BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,500P,PP03,SV,500-BAS-SV-10

    MDR report key: 9811382 · Received March 10, 2020

    Report

    Report Number
    3004123209-2020-00060
    Event Type
    Death
    Date Received
    March 10, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 27, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 16TH APRIL 2012. THE DEVICE WAS REPORTED AS BEING USED DURING A PATIENT INVOLVED EVENT ON (B)(6) 2020. THE EVENT WAS 14 MINUTES 14 SECONDS IN DURATION. THE PADS WERE ADHERED TO THE PATIENT 1 MINUTE 37 SECONDS AFTER THE DEVICE WAS SWITCHED ON. THE PATIENT PRESENTED ASYSTOLE WHICH IS A NON-SHOCKABLE RHYTHM AND THUS, A SHOCK WAS NOT DELIVERED. THE DEVICE PROMPTED THE USER TO BEGIN CPR AT 00:01:51 AND CHEST COMPRESSIONS BEGAN AT 00:01:55. THERE WERE PAUSES IN COMPRESSIONS BETWEEN 00:02:29 AND 00:02:35, 00:02:54 AND 00:03:00, 00:03:19 AND 00:03:25 AND 00:03:46 AND 00:03:54. THE DEVICE PROMPTED THE USER TO STOP CPR AT 00:03:57 AND CHEST COMPRESSIONS STOPPED AT 00:04:00. THE PATIENT REMAINED IN ASYSTOLE, AND A SHOCK WAS NOT DELIVERED. THE DEVICE PROMPTED THE USER TO BEGIN CPR AT 00:04:12 AND COMPRESSIONS BEGAN AT 00:04:16. THERE WERE PAUSES IN COMPRESSIONS BETWEEN 00:04:41 AND 00:04:48, 00:05:09 AND 00:05:15, 00:05:33 AND 00:05:41 AND 00:06:06 AND 00:06:15. THE DEVICE PROMPTED THE USER TO STOP CPR AT 00:06:17 AND CHEST COMPRESSIONS STOPPED AT 00:06:19. THE PATIENT REMAINED IN ASYSTOLE, AND A SHOCK WAS NOT DELIVERED. THE DEVICE PROMPTED THE USER TO BEGIN CPR AT 00:06:36 AND COMPRESSIONS BEGAN AT 00:06:39. THERE WERE PAUSES IN COMPRESSIONS BETWEEN 00:06:57 AND 00:07:08 AND 00:07:26 AND 00:07:30. THE DEVICE PROMPTED THE USER TO STOP CPR AT 00:08:41 AND CHEST COMPRESSIONS STOPPED AT 00:08:46. THE PATIENT REMAINED IN ASYSTOLE, AND A SHOCK WAS NOT DELIVERED. THE DEVICE PROMPTED THE USER TO BEGIN CPR AT 00:09:03 AND COMPRESSIONS BEGAN AT 00:09:07. THERE WERE PAUSES IN COMPRESSIONS AT 00:10:33 AND 00:10:36 AND 00:11:11 AND 00:11:30. THE DEVICE PROMPTED THE USER TO STOP CPR AT 00:13:33 AND CHEST COMPRESSIONS STOPPED AT 00:13:35. THE PATIENT REMAINED IN ASYSTOLE, AND A SHOCK WAS NOT DELIVERED. THE DEVICE PROMPTED THE USER TO BEGIN CPR AT 00:13:48 AND COMPRESSIONS STARTED AT 00:13:48. COMPRESSIONS WERE DELIVERED UNTIL THE PADS WERE REMOVED AT 00:13:54. GIVEN THE LIMITED AVAILABLE DATA TO REVIEW, THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORT OF A SHOCK BEING ADVISED. A POSSIBLE SCENARIO THAT COULD HAVE RESULTED IN, A SHOCK BEING ADVISED AND THEN SUBSEQUENTLY DISARMED, IS THE CONTINUATION OF CPR DURING THE ANALYSIS PHASE. THIS COULD HAVE CAUSED THE ALGORITHM TO INITIALLY DETECT CHANGES IN THE ECG WHICH WOULD BE REPRESENTATIVE OF A SHOCKABLE RHYTHM. IN SUCH A SCENARIO, A SHOCK ADVISED PROMPT COULD HAVE INITIALLY BEEN ISSUED AND THEN ONCE CPR WAS TERMINATED THE DEVICE WOULD HAVE REVERTED TO NO SHOCK ADVISED. ALTERNATIVELY, A BORDERLINE ECG COULD HAVE RESULTED IN SUCH A SCENARIO. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THIS EVENT. A SHOCK WAS NOT DELIVERED BECAUSE THE PATIENT DID NOT PRESENT IN A SHOCKABLE RHYTHM.

    Description of Event or Problem · 0

    DEVICE USED ON CARDIAC ARREST PATIENT. THE THREE FIREFIGHTERS STARTED CPR, CONNECTED THE HEART STARTER. ALL THREE SAY THEY HEARD THE SAYING "REMOVE YOU FROM THE PATIENT" "SHOCK RECOMMENDED" THEY PRESSED THE HEARTBEAT BUTTON WHICH DID NOT BLINK. IT WAS REPEATED THREE TIMES BEFORE THE AMBULANCE TOOK OVER. NO SHOCK DELIVERED BY DEVICE, PATIENT EXPIRED.

    Description of Event or Problem · 0

    DEVICE USED ON CARDIAC ARREST PATIENT. HE THREE FIREFIGHTERS STARTED CPR, CONNECTED THE HEART STARTER. ALL THREE SAY THEY HEARD THE SAYING "REMOVE YOU FROM THE PATIENT" "SHOCK RECOMMENDED" THEY PRESSED THE HEARTBEAT BUTTON WHICH DID NOT BLINK. IT WAS REPEATED THREE TIMES BEFORE THE AMBULANCE TOOK OVER. NO SHOCK DELIVERED BY DEVICE, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277054 PACKAGE,500P,PP03,SV,500-BAS-SV-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death