BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN SAM 300P AND PAD PAK

    MDR report key: 2852503 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00026
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 14, 2010
    Report Date
    October 10, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD.
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    NOT KNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO AN INSECURE WELD ON A TAG IN THE BATTERY PACK. A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THAT THIS WAS THE FIRST COMPLAINT OF THIS TYPE REC'D. THE LOOSE TAG IN THE BATTERY PACK WAS ONLY HELD IN PLACE BY THE HEATSHRINK WRAP. IT IS FELT LIKELY THAT THE TAG BECAME DISLODGE WHEN THE DEVICE WAS MOVED FOR USE. THE BATTERY PACK WAS RETURNED TO THE SUPPLIER IN ORDER FOR CORRECTIVE AND PREVENTATIVE ACTIONS TO BE PUT IN PLACE. THE PAD-PAK (BATTERIES AND ELECTRODES) USED IN THE DEVICE IS FOR SINGLE USE ONLY BUT THE PAD 300P DEFIBRILLATOR IS A MULTI USE DEVICE. IT IS NOT KNOWN IF THIS WAS THE FIRST USE OF THE PAD 300P DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS USED ON A PT AND DURING USE A "LOW BATTERY WARNING" WAS ISSUED. THE OUTCOME FOR THE PT IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1