BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ADULT/CHILD PLUS PADS

    MDR report key: 24007021 · Received January 8, 2026

    Report

    Report Number
    3030677-2026-100020
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 23, 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

    THE PARENT RECORD HAS BEEN IDENTIFIED AS A DUPLICATE OF PR 6834460, REPORTED UNDER MDR NUMBER 3030677-2026-100018. THIS CASE WILL BE CLOSED DUE TO DUPLICATION. PLEASE REFER TO (B)(4) FOR THE COMPLETE INVESTIGATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART ADULT/CHILD PLUS PADS (M3713A) AND LOT NO. 072825-01 HAD AN INCONSISTENT GEL CONDITION; ONE PAD APPEARED YELLOWISH AND UNEVEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64038 HEARTSTART ADULT/CHILD PLUS PADS DEFIBRILLATOR PADS MKJ PHILIPS MEDICAL SYSTEMS M3713A 072825-01 00884838111325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown