BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,450P,PP01,EN,450-STR-US-10

    MDR report key: 9652391 · Received January 31, 2020

    Report

    Report Number
    3004123209-2020-00021
    Event Type
    Death
    Date Received
    January 31, 2020
    Date of Event
    December 5, 2019
    Report Date
    February 21, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM450P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 450P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 450P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 19TH MAY 2015. THE DEVICE WAS POWERED ON AND THE USER WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS. THE ELECTRODE PADS WERE BRIEFLY DETECTED AS BEING PLACED 1 MINUTE AND 26 SECONDS AFTER POWER ON. HOWEVER, POWER APPEARS TO HAVE BEEN REMOVED FROM THE DEVICE SHORTLY AFTER RESULTING IN NO ANALYSIS OF THE PATIENT¿S HEART RHYTHM. THIS MAY SUGGEST THE PAD-PAK WAS REMOVED OR HAD BEEN INCORRECTLY SEATED WITHIN THE DEVICE. THE DEVICE WAS IMMEDIATELY POWERED ON AGAIN, BUT THE ELECTRODE PADS WERE NOT DETECTED AS BEING ATTACHED. THE DEVICE WAS SUBSEQUENTLY POWERED OFF AFTER 1 MINUTES AND 5 SECONDS. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE RANGE EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. IN THE ABSENCE OF THE PATIENT, THE INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT. THE FAULT MAY HAVE BEEN DUE TO A NUMBER OF THINGS, FOR EXAMPLE, PAD POSITIONING EXCESSIVE HAIR OR AN INCORRECTLY SEATED PAD-PAK. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. A SAMARTIAN 450P DEVICE WAS USED DURING AN ALLEGED SCA IN THE USA. THE RESPONDER REMOVED PADS FROM DEVICE AND PLACED ON THE PATIENT. IT WAS ALLEGED THAT THE UNIT KEPT CYCLING THROUGH THE PROMPTS AND WOULD NOT PROGRESS TO ANALYZE FOR SHOCK THERAPY. THE RESPONDER USED AN ALTERNATIVE DEVICE TO PROVIDE THERAPY. CUSTOMER STATED THAT THE PATIENT DID NOT SURVIVE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. (B)(4).

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. A SAMARTIAN 450P DEVICE WAS USED DURING AN ALLEGED SCA IN THE USA. THE RESPONDER REMOVED PADS FROM DEVICE AND PLACED ON THE PATIENT. IT WAS ALLEGED THAT THE UNIT KEPT CYCLING THROUGH THE PROMPTS AND WOULD NOT PROGRESS TO ANALYZE FOR SHOCK THERAPY. THE RESPONDER USED AN ALTERNATIVE DEVICE TO PROVIDE THERAPY. CUSTOMER STATED THAT THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117848 PACKAGE,450P,PP01,EN,450-STR-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 450P M727SAM450P

    Patients

    Seq Age Sex Outcome Treatment
    1 Death