BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,USB,EN,500-BAS-CN-10

    MDR report key: 8446719 · Received March 24, 2019

    Report

    Report Number
    3004123209-2019-00128
    Event Type
    Malfunction
    Date Received
    March 24, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 15, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE OUT QAT RECORDS WERE REVIEWED AND THIS CONFIRMED THAT ALL 55 DEVICES WERE PROGRAMMED WITH US ENGLISH LANGUAGE PRIOR TO DISPATCH FROM HEARTSINE. THE SAM 500P DEVICES PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 11TH MARCH 2019. REPORTED ISSUE CONFIRMED. ALL 55 X 500P ENGLISH DEVICES WERE FOUND TO BE INCORRECTLY LABELLED AS FRENCH ON THE OUTER PAD BOX LABELLING. DURING THE SITE VISIT ON THE 22ND MARCH 2019, A CORRECTION WAS PERFORMED TO THE OUTER PAD BOX LABELLING. THE FAULT WILL BE FURTHER INVESTIGATED UNDER NC ((B)(4)).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED. SERIAL NUMBER HAVE BEEN PROVIDED FOR THE 55 DEVICES WHICH WERE MISLABELLED. THE ORIGINAL SERIAL NUMBER WAS ENTERED AS THE DELIVERY ORDER. (B)(6).

    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

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE DID NOT HAVE THE REQUIRED LANGUAGE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE DID NOT HAVE THE REQUIRED LANGUAGE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE DID NOT HAVE THE REQUIRED LANGUAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239704 PACKAGE,500P,PP03,USB,EN,500-BAS-CN-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1