BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 10792776 · Received November 5, 2020

    Report

    Report Number
    3004123209-2020-00353
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAULT FOUND ON THE RETURNED SAM 300P. POTENTIAL USER ERROR. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED AND SHOWED THAT A PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2011. DURING THE REPORTED PATIENT-INVOLVED EVENT ON THE (B)(6) 2020, THE DEVICE WAS POWERED ON WITH THE PADS ATTACHED; HOWEVER, THE PATIENT IMPEDANCE WAS BELOW THE ACCEPTABLE RANGE. THE IMPEDANCE WENT IN-RANGE AT 00:00:27 BUT CONTINUED TO FALL OUT-OF-RANGE THROUGHOUT THE EVENT. THE USER WAS THEREFORE REPEATEDLY ADVISED TO ¿CHECK PADS, PRESS PADS FIRMLY TO PATIENT¿S BARE SKIN¿. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE 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. THE DEVICE HAD ANALYSED MULTIPLE PATIENT RHYTHMS WITHOUT ISSUING ¿CHECK PADS¿ PROMPTS, INDICATING NO ISSUE WITH THE IMPEDANCE DETECTION AT THESE TIMES. THE FAULT MAY HAVE BEEN DUE TO ANY NUMBER OF THINGS, FOR EXAMPLE, INCORRECTLY POSITIONED OR POORLY ADHERED PADS. ALTERNATIVELY, MOISTURE MAY HAVE BEEN PRESENT ON THE SKIN, RESULTING IN LOW IMPEDANCE MEASUREMENTS. HOWEVER, THIS COULD NOT BE CONFIRMED AND NO PAD-PAK WAS RETURNED FOR INVESTIGATION. FURTHERMORE, THE DEVICE RECORDED A SHOCK KEY ERROR ON THE (B)(6) 2017 DURING A MANUAL POWER ON. NO MEASURABLE FAULT WAS IDENTIFIED ON THE SHOCK KEY LINES AND THE DEVICE PASSED ALL SELF-TESTS DURING THE INVESTIGATION. THE SHOCK KEY FAULT COULD ONLY BE REPLICATED BY HOLDING THE SHOCK BUTTON DURING POWER ON. THIS MAY SUGGEST THE FAULT WAS DUE TO AN EXTERNAL FORCE BEING APPLIED TO THE SHOCK BUTTON DURING THIS POWER ON. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.

    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
    1254929 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization