BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6449353 · Received March 31, 2017

    Report

    Report Number
    3004123209-2017-00269
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 3, 2017
    Report Date
    May 25, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE CORROSION OBSERVED ON MULTIPLE TRACKS ON THE MEMBRANE TAIL WOULD INDICATE THAT THE DEVICE HAD BEEN STORED IN ADVERSE CONDITIONS. THERE WAS FURTHER EVIDENCE OF THIS THROUGHOUT THE HISTORY LOG, WHERE THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE IS RECORDED OUTSIDE THE RECOMMENDED OPERATING RANGE OF 0-50°C WITH A LOW OF -2.0°C RECORDED

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SERVICE PROMPT REQUIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232034 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1