BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8948788 · Received August 30, 2019

    Report

    Report Number
    3004123209-2019-00303
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 17, 2019
    Report Date
    November 17, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 2ND MAY 2012. THE RETURNED PAD-PAK DHR WAS INVESTIGATED SHOWING IT WAS 1 OF 200 PAD-PAK¿S MANUFACTURED ON THE 6TH JUNE 2012 FROM LOT: A1288, 198 OF WHICH WERE SHIPPED TO HEARTSINE INC ON THE 7TH JUNE 2012. INFORMATION FROM THE HISTORY LOG SHOWED THE DEVICE HAD BEEN INSTALLED FOR 6 YEARS AND 5 MONTHS PRIOR TO ISSUING THE FIRST LOW BATTERY WARNING FROM THE 27TH JANUARY 2019. THE USER WOULD HAVE BEEN ALERTED WITH ¿WARNING, LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPTS, ALONGSIDE A FLASHING RED STATUS LED, AS PER THE REPORTED FAULT. INFORMATION FROM THE DHR FOR PAD-PAK LOT: A1288 SHOWED THE RETURNED PAD-PAK WAS MANUFACTURED ON THE 6TH JUNE 2012 AND WAS THEREFORE LIKELY THE PAD-PAK USED WITH THE DEVICE SINCE INSTALLATION ON THE 20TH AUGUST 2012. THIS PAD-PAK HAD AN EXPIRY DATE OF SEPTEMBER 2016 AND HAD THEREFORE EXPIRED 2 YEARS AND 4 MONTHS PRIOR TO THE FIRST LOW BATTERY FAIL. THE REPORTED LOW BATTERY WARNINGS WOULD THEREFORE HAVE BEEN TRIGGERED BY THIS EXPIRED PAD-PAK. DURING INVESTIGATION, NO FAULT WAS FOUND ON THE SAM 300P THAT WOULD HAVE RESULTED IN A LOW BATTERY FAIL. THE DEVICE BATTERY MONITORING FUNCTIONALITY, CURRENT DRAIN AND POGO PINS WERE VERIFIED DURING INVESTIGATION AND THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A SAM 350P.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    FLASHING RED AND STATES LOW BATTERY DEVICE SERVICE REQUIRED. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    FLASHING RED AND STATES LOW BATTERY DEVICE SERVICE REQUIRED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743804 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1