BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 17393444 · Received July 25, 2023

    Report

    Report Number
    3030677-2023-02965
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 17, 2023
    Report Date
    September 9, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    K021453
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. A REPORT WAS RECEIVED TWO WEEKS AFTER AN INCIDENT IN THE CARDIAC OR DURING A REDO OPERATIONAL PROCEDURE, INVOLVING A MALE ADULT PATIENT WHO EXPERIENCED A STAGE 1 (1ST DEGREE) BURN ON HIS BACK AFTER IMPROPERLY USING SMARTPADS II DURING A CABG (CORONARY ARTERY BYPASS GRAFT) PROCEDURE. THE USER USED PADS WITH CODE M3713A, WHICH WERE FOUND TO BE NOT PROPERLY INTACT UPON OPENING THE PACKAGE. THE PADS WERE DISCARDED WITHOUT EVALUATION AFTER THE INCIDENT. INSTEAD OF THE APPROPRIATE RADIOLUCENT PADS M3713A, M3716A PADS WERE USED IN THE OR DUE TO OUT-OF-STOCK CIRCUMSTANCES. IN RESPONSE, ALL M3713A PADS WERE RETURNED TO THE PHARMACY, AND THE FACILITY IS ORDERING THE CORRECT PADS THEY USED BEFORE TO PREVENT SIMILAR OCCURRENCES IN THE FUTURE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE PATIENT EXPERIENCING A STAGE 1 (1ST DEGREE) BURN ON HIS BACK AFTER INCORRECTLY USING SMARTPADS II (M3713A) DURING A CABG PROCEDURE, AS THE PADS WERE USED IN AN IMPROPER POSITION CONTRARY TO THE DEVICE'S INSTRUCTIONS. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. 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. THE RESOLUTION INVOLVED THE CAREGIVER APPLYING OINTMENT TO THE AFFECTED LOCATION ON THE PATIENT'S BACK WHERE THE STAGE 1 BURN OCCURRED AFTER USING SMARTPADS II (M3713A) IN AN IMPROPER POSITION, LEADING TO THE DISCONTINUATION OF FOLLOW-UP CLINICAL USE OF THE DEVICE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. H3 OTHER TEXT : THE PADS WERE DISCARDED WITHOUT EVALUATION AFTER THE INCIDENT.

    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. REPORTER PHONE AND REPORTING INSTITUTION PHONE: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTION: THE EVENT DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY, THEREFORE, THIS REPORT HAS BEEN UPDATED FROM SERIOUS INJURY TO PRODUCT PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD STAGE 1 BURN AFTER USING SMARTPADS ON HIS BACK. THE BURN WAS IDENTIFIED AFTER PATIENT FINISHED CABG PROCEDURE. THE PADS WERE BEING USED WITH THE HEARTSTART XL DEFIBRILLATOR.

    Description of Event or Problem · 0

    CORRECTION: THE EVENT DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY, THEREFORE, THIS REPORT HAS BEEN UPDATED FROM SERIOUS INJURY TO PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697392 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening