BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6463508 · Received April 6, 2017

    Report

    Report Number
    3004123209-2017-00272
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 7, 2017
    Report Date
    May 13, 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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD ( MANUFACTRER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER) THERE WERE SEVERAL TEN-MINUTE POWER ONS BETWEEN (B)(6) 2015 (B)(6) 2016. PREVIOUS EXPERIENCE HAS SHOWN THAT FAULTS OF THE REPORTED NATURE CAN BE CHARACTERISED BY MULTIPLE MANUAL POWER UPS, MAINLY OF TEN-MINUTES DURATION, DUE TO A MEMBRANE FAILURE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. MEMORY FULL PROMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250995 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1