BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM ADULT PADS

    MDR report key: 16507188 · Received March 8, 2023

    Report

    Report Number
    3030677-2023-01009
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    December 20, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838002876
    PMA / PMN Number
    K002806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PADS CONNECTOR PROJECT, LC1195-011 [REF-02], CHANGED THE PADS CONNECTOR ASSEMBLY SUPPLIER FROM DICKTEN MASCH TO NEW DEANTRONICS FOR PART NUMBERS M3718A AND M3719A. AS PART OF THE PROJECT, THE HAZARDOUS SUBSTANCE COMPLIANCE EVIDENCE WAS UPDATED ON 17-JAN-2023, PHILIPS WAS NOTIFIED THAT THE WIRING INSULATION OF THE DICKTEN MASCH CONNECTOR ASSEMBLIES USED TO MANUFACTURE M3718A AND M3719A PADS CONTAIN A PVC COMPOUND MATERIAL COMPRISED OF 20-30% DEHP MATERIAL. THIS MATERIAL HAS BEEN USED SINCE INITIAL PRODUCTION RELEASE. THIS LEVEL OF DEHP MATERIAL DOES NOT COMPLY WITH THE REGULATIONS. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS IDENTIFIED AS INADEQUATE PROCESS. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, FURTHER ACTION HAS BEEN INITIATED. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. ANALYSIS WAS PERFORMED AND INVESTIGATION HAS BEEN COMPLETED. ALL PADS IN THE FIELD HAVE EXPIRED. PER DICKTEN MASCH, THE LAST SHIPMENT OF M3718/M3719A PADS WAS RELEASED IN MAY 2021 AND EXPIRED 04-APR-2023. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE PADS CONNECTOR PROJECT, CHANGED THE ALS PADS CONNECTOR ASSEMBLY SUPPLIER (TIER 2) FOR PART NUMBERSM3718A. AS PART OF THE PROJECT, THE HAZARDOUS SUBSTANCE COMPLIANCE EVIDENCE WAS UPDATED. ON 25-JAN-2023, IT WAS DISCOVERED THAT THE NEW SUPPLIER'S WIRING INSULATION OF THE CONNECTOR ASSEMBLIES USED TO MANUFACTURE M3718A PADS WIRING INSULATION CONTAINS A PVC COMPOUND MATERIAL COMPRISED OF 20-30% DEHP MATERIAL. THIS MATERIAL HAS BEEN USED SINCE INITIAL PRODUCTION RELEASE. THIS LEVEL OF DEHP MATERIAL DOES NOT COMPLY WITH THE FOLLOWING REGULATIONS: *ROHS2; *ROHS3; *PROPOSITION 65; *REACH. PHTHALATES HAVE BEEN IN THE M3718A WIRE INSULATION MATERIAL SINCE INITIAL PRODUCTION RELEASE. THERE WAS NO PATIENT INVOLVEMENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735782 HEARTSTREAM ADULT PADS DEFIBRILLATOR PADS MKJ PHILIPS NORTH AMERICA LLC M3718A 00884838002876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown