BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 10792777 · Received November 5, 2020

    Report

    Report Number
    3004123209-2020-00354
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 15, 2020
    Report Date
    January 29, 2021
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO CONFIRM THE REPORTED FAULT, THE DEVICE WAS NOT POWERED ON DURING REPORTED SCA EVENT. THE DEVICE WAS REPORTED TO HAVE BEEN THE SECOND DEVICE USED DURING A PATIENT-INVOLVED EVENT ON THE (B)(6) 2020. INFORMATION FROM THE DEVICE MEMORY INDICATES THE LAST LOG ENTRY OCCURRED ON THE (B)(6) 2020 DURING THE WEEKLY AUTO SELF-TEST. THIS WOULD INDICATE THAT THE DEVICE HAD NOT BEEN POWERED ON DURING THE REPORTED SCA EVENT. THE LAST RECORDED POWER ON OF THE DEVICE OCCURRED ON THE (B)(6) 2018. DURING THE INVESTIGATION, THE DEVICE WAS POWERED ON MULTIPLE TIMES. NO FAULT WAS IDENTIFIED THAT WOULD HAVE PREVENTED THE DEVICE FROM POWERING ON. THE DEVICE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE SPECIFIED RANGE, EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. THE DEVICE DELIVERED THE FULL SHOCK THERAPY SEQUENCE WITHOUT FAULT AND WAS CONFIRMED TO RECORD ECG DATA ACCURATELY WITHOUT NOISE OR OTHER ABNORMALITIES. INFORMATION FROM THE DEVICE MEMORY INDICATES THE DEVICE HAD BEEN PREVIOUSLY USED IN MULTIPLE PATIENT-INVOLVED EVENTS THROUGHOUT ITS TIME IN SERVICE. TWO OF THESE POWER ONS RECORDED ¿CHECK PADS¿ PROMPTS CONTINUOUSLY FOR EXTENDED PERIODS OF TIME UNTIL THE DEVICE WAS MANUALLY POWERED OFF. THIS WOULD SUGGEST THAT THE PADS HAD BEEN REMOVED BY THE USER AFTER CONCLUDING THERAPY, WHILE THE DEVICE REMAINED POWERED ON. THE DEVICE WAS REPORTED TO HAVE ISSUED ¿PRESS PADS FIRMLY¿ PROMPTS ON THE DATE OF SCA ON THE (B)(6) 2020. GIVEN NO POWER ONS WERE RECORDED ON THIS DATE AND NO FAULT WAS FOUND ON THE DEVICE AFTER EXTENSIVE INVESTIGATION AT HEARTSINE, THE REPORTED FAULT COULD NOT BE CONFIRMED. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT AT A NURSING HOME IN THE US. IT WAS REPORTED THAT DURING AN ALLEGED SCA THE UNIT WAS PLACED ONTO A PATIENT. THE DEVICE KEPT PROMPTING "PRESS PADS FIRMLY". ANOTHER DEVICE WAS RETRIEVED, AND IT WAS REPORTED THAT ONCE THE SECOND DEVICE ARRIVED THE UNIT WAS OPENED, AND PADS WERE APPLIED TO THE PATIENT¿S CHEST. THE DEVICE YET AGAIN DISPLAYED THE "PRESS PADS FIRMLY" MESSAGE. THIS THEN RESULTED IN THE CUSTOMER HAVING TO RUN AND GRAB A 3RD DEFIB TO SUCCESSFULLY DELIVER A SHOCK. THE CUSTOMER WAS UNABLE TO VERIFY THE PAD EXPIRATION DATE AS THEY DISPOSED OF THE PADS FOR THIS UNIT. IT WAS ALSO REPORTED THAT THE PATIENT DID SURVIVE THIS EVENT AND IS CURRENTLY IN THE ICU AT A LOCAL HOSPITAL."

    Description of Event or Problem · 1

    THIS WAS A PATIENT INVOLVED EVENT AT A NURSING HOME IN THE US. IT WAS REPORTED THAT DURING AN ALLEGED SCA THE UNIT WAS PLACED ONTO A PATIENT. THE DEVICE KEPT PROMPTING "PRESS PADS FIRMLY". ANOTHER DEVICE WAS RETRIEVED, AND IT WAS REPORTED THAT ONCE THE SECOND DEVICE ARRIVED THE UNIT WAS OPENED, AND PADS WERE APPLIED TO THE PATIENT¿S CHEST. THE DEVICE YET AGAIN DISPLAYED THE "PRESS PADS FIRMLY" MESSAGE. THIS THEN RESULTED IN THE CUSTOMER HAVING TO RUN AND GRAB A 3RD DEFIB TO SUCCESSFULLY DELIVER A SHOCK. THE CUSTOMER WAS UNABLE TO VERIFY THE PAD EXPIRATION DATE AS THEY DISPOSED OF THE PADS FOR THIS UNIT. IT WAS ALSO REPORTED THAT THE PATIENT DID SURVIVE THIS EVENT AND IS CURRENTLY IN THE ICU AT A LOCAL HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254930 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization