BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ADULT/CHILD PLUS PADS

    MDR report key: 24007013 · Received January 8, 2026

    Report

    Report Number
    3030677-2026-100018
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 22, 2025
    Report Date
    April 24, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838111325
    PMA / PMN Number
    K002806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT, AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY LOCAL PHILIPS PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT REGARDING THE PHILIPS M3713A MULTIFUNCTION ADULT/CHILD ELECTRODE PADS PLUS, INDICATING THAT PADS WITH LOT NO. 072825-01, MANUFACTURED IN 2025, APPEAR TO HAVE COLOR VARIATIONS ACROSS PADS, ABNORMAL OR UNEVEN ADHESION, AND INCONSISTENT GEL CONDITIONS. NO PATIENT INVOLVEMENT WAS REPORTED. THE AFFECTED PADS HAVE NOT BEEN RETURNED TO PHILIPS FOR FURTHER INVESTIGATION. HOWEVER, THE CUSTOMER HAS PROVIDED PICTURES AND A VIDEO OF THE ALLEGED DEFECT. THE MANUFACTURER REVIEWED THE PICTURES AND VIDEO AND CONFIRMED THE DEFECT WITH THE PADS' LINER. BASED ON THE AVAILABLE INFORMATION AND REVIEW OF THE IMAGES/VIDEO, THE REPORTED PROBLEM WAS CAUSED BY A MATERIAL FAILURE OF THE PADS' GEL LINER. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF ADDITIONAL ANALYSIS, FURTHER ACTION HAS BEEN INITIATED. THE CUSTOMER WAS PROVIDED WITH REPLACEMENT PADS TO RESOLVE THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART ADULT/CHILD PLUS PADS (M3713A) AND LOT NO. 072825-01 HAVE DIFFERENT COLORS BETWEEN THE TWO PADS IN THE SAME SET. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161690 HEARTSTART ADULT/CHILD PLUS PADS DEFIBRILLATOR PADS MKJ PHILIPS MEDICAL SYSTEMS M3713A 072825-01 00884838111325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown