BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08

    MDR report key: 8168276 · Received December 17, 2018

    Report

    Report Number
    3004123209-2018-00745
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 30, 2018
    Report Date
    April 16, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2018. THE DEVICE WAS RETURNED FOR ¿RED LED STATUS FLASH AND ALARM SOUND¿. THE +VE POGO PIN DID NOT PRESENT A SIGNIFICANT RESISTANCE WHEN PRESSED. THIS DEFECT WOULD ACCOUNT FOR THE LOW BATTERY WARNINGS DETAILED IN THE HISTORY LOG, DUE TO AN INTERMITTENT BATTERY TERMINAL CONNECTION WHEN A PAD-PAK WAS INSTALLED. THE RETURNED PAD-PAK WAS MEASURED, AND THE BATTERY VOLTAGES WERE FOUND TO BE CONSISTENT WITH THAT OF AN EXPIRY OF MAY 2022 AND WOULD NOT HAVE BEEN LOW ENOUGH TO TRIGGER A LOW BATTERY WARNING. THE DEVICE SUCCESSFULLY PASSED FINAL UNIT TEST, H032-014-004, ON THE (B)(6) 2018. THEREFORE, THIS REPORT CONCLUDES THAT THE COMPONENT FAILED AFTER DISPATCH FROM HEARTSINE. 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 ANOTHER DEVICE OF THE SAME MODEL.

    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

    RED LED FLASH AND ALARM SOUND. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    RED LED FLASH AND ALARM SOUND. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010285 PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1