BEUDAMED
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    HEARTSINE SAMARITAN 300P AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 15, 2018

    PACKAGE,350P,PP01,EN,350-BAS-US-10

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 3, 2019

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 8, 2018

    PACKAGE,350P,PP01,EN,350-STR-US-10

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·September 10, 2024

    PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code NSA·October 30, 2024

    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation

    FDA Enforcement
    Class I ·Terminated·Heartsine Technologies, Limited·November 7, 2012

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    FDA Enforcement
    Class II ·Terminated·Heartsine Technologies, Limited·July 30, 2014

    PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 26, 2020

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    FDA Recall
    Terminated ·Heartsine Technologies, Limited 203 Airport Road West Belfast United Kingdom·Product code MKJ·June 12, 2014

    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation

    FDA Recall
    Terminated ·Heartsine Technologies, Limited 203 Airport Road West Belfast United Kingdom·Product code MKJ·September 13, 2012