BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10

    MDR report key: 18955318 · Received March 21, 2024

    Report

    Report Number
    3004123209-2024-00032
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 7, 2024
    Report Date
    June 18, 2024
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION CONFIRMED THE REPORTED FAULT AS THE DEVICE WAS UNABLE TO DELIVER ANY SHOCK ENERGY. THE FAULT WAS ATTRIBUTED TO THE FAILURE OF CAPACITOR C22. UPON REPLACING CAPACITOR C22 THE DEVICE DELIVERED MULTIPLE TEST SHOCKS WITHOUT FAULT. THE DEVICE WAS SCRAPPED BY HEARTSINE AND THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT DELIVER SHOCK ENERGY. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE 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 COULD NOT DELIVER SHOCK ENERGY. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555210 PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) NSA HEARTSINE TECHNOLOGIES LTD 350P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown