BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP01,EN,350-STR-US-10

    MDR report key: 20387795 · Received October 7, 2024

    Report

    Report Number
    3004123209-2024-00174
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 17, 2024
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION DETERMINED THE ROOT CAUSE OF THE REPORTED FAULT TO BE A DAMAGED SPEAKER CABLE. UPON RECEIPT, THE DEVICE WOULD NOT ISSUE AUDIO PROMPTS AS PER THE REPORTED FAULT. A VISUAL INSPECTION OF THE SPEAKER CABLES IDENTIFIED THAT THE BLACK CABLE WAS SEVERED IN THE REGION WHERE THE RIM OF THE UPPER CASE MEETS THE LOWER CASE. THIS INDICATES THAT THE CABLE HAD BEEN DAMAGED DURING PAIRING OF THE TWO CASES AT MANUFACTURE. THE FAULT COULD NOT BE REPLICATED AFTER REPLACING THE SPEAKER. THIS CONFIRMED A FAILURE OF THE RETURNED SPEAKER DUE TO THE SEVERED SPEAKER CABLE. THE DEVICE WAS SCRAPPED BY HEARTSINE AND THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO ISSUE AUDIO PROMPTS AT POWER UP. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO ISSUE AUDIO PROMPTS AT POWER UP. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282666 PACKAGE,350P,PP01,EN,350-STR-US-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) NSA HEARTSINE TECHNOLOGIES LTD SAM 350P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown