BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8263059 · Received January 19, 2019

    Report

    Report Number
    3004123209-2019-00039
    Event Type
    Malfunction
    Date Received
    January 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 16, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE 15TH MARCH 2011. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿AED SHOCK BUTTON FAULTY¿. INFORMATION FROM THE HISTORY LOG SHOWS THAT THE DEVICE SUCCESSFULLY RECORDS SELF-TESTS FROM THE FIRST PAD-PAK INSTALLATION DATE ON THE 1ST MAY 2011 UP TO THE LAST LOG ENTRY, PRIOR TO RECEIPT AT HEARTSINE, ON THE 5TH MARCH 2019. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. FURTHER INFORMATION OBTAINED FROM THE DISTRIBUTOR, HTM MEDICO, STATED THE FAULTS WERE DISCOVERED DURING ROUTINE TESTING OF THE DEVICE ON SAVEREVO IN WHICH THE SHOCK BUTTON WAS TESTED (SEE ATTACHED DISTRIBUTOR EMAIL [4]). THE SHOCK BUTTON WAS VERIFIED DURING THE INVESTIGATION AND USING THE SAVEREVO DIAGNOSTIC TOOL DURING TESTING. THEREFORE, IT IS POSSIBLE THAT INCORRECT USE OF SAVEREVO DIAGNOSTIC TEST TOOL MAY HAVE CAUSED THE REPORTED ISSUE. THE RETURNED SAM 500P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    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. AED SHOCK KEY NOT WORKING.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. AED SHOCK KEY NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55886 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1