BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH

    MDR report key: 23751982 · Received December 8, 2025

    Report

    Report Number
    3004123209-2025-00481
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 30, 2025
    Report Date
    December 18, 2025
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Removal / Correction Number
    RA2025-4068245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR REPORT WITH FDA REFERENCE# 3004123209-2025-00481 AND STRYKER REFERENCE# 4193181, SUBMITTED ON 12/09/2025, WAS SUBMITTED IN ERROR. THE CUSTOMER CONFIRMED THERE WAS NO EVIDENCE OF BENT PINS.

    Additional Manufacturer Narrative · 0

    THE PAD-PAK WAS NOT RETURNED TO HEARTSINE FOR EVALUATION. THE CUSTOMER HAS BEEN INSTRUCTED TO DISPOSE OF THE AFFECTED UNIT FOLLOWING LOCAL WASTE DISPOSAL REGULATIONS. THE CUSTOMER WAS SENT A REPLACEMENT PAD-PAK. A CAPA INVESTIGATION DETERMINED MULTIPLE POTENTIAL CAUSES OF THE FAULT, BOTH INTERNAL AND EXTERNAL TO STRYKER MANUFACTURING PROCESSES, THE PRIMARY ROOT CAUSE WAS DETERMINED TO BE PRESSURE APPLIED ONTO THE LOCATOR PINS DURING HANDLING/PACKAGING.

    Description of Event or Problem · 0

    IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Description of Event or Problem · 0

    IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739415 HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH AUTOMATED EXTERNAL DEFIBRILLATOR ELECTRODE MKJ HEARTSINE TECHNOLOGIES LTD PAD-PAK-03 A5364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown