BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSYNC BY NISSHA MEDICAL

    MDR report key: 16136730 · Received January 11, 2023

    Report

    Report Number
    1317188-2023-00001
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    November 24, 2022
    Report Date
    June 23, 2023
    Manufacturer
    GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES
    Product Code
    MKJ
    PMA / PMN Number
    K080421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF NMT'S RISK MANAGEMENT DOCUMENTS WAS COMPLETED TO IDENTIFY FACTORS THAT CONTRIBUTE TO PRODUCT RISK AND PATIENT SAFETY. THESE DOCUMENTS INCLUDE: HRT-(B)(4)- HAZARDS ANALYSIS, HRT-(B)(4) - UFMEA, HRT-(B)(4) - DFMEA. THE REVIEW IDENTIFIED HAZARDS TO PATIENT SAFETY FOUND POOR PAD ADHESION TO PATIENT'S SKIN CAN CAUSE BURNS AT THE DETACHMENT SITE. POOR CONTACT ALLOWS FOR ENERGY DISPERSION GENERATING THE ARC CURRENT. WITHIN THE DFMEA, POOR PAD ADHESION OF THE HYDROGEL HAS BEEN IDENTIFIED AT A FAILURE MODE AS WELL AS CHEMICAL SKIN REACTION LEADING TO A PATIENT BURN. IN BOTH CASES, RISK MITIGATION HAS BEEN COMPLETED BY COMPLYING WITH IEC 60601-2-4 AND ISO 10993 STANDARDS, WEARABILITY DESIGN VERIFICATION STUDY, ADHESION PEEL STUDY, AND THE FORMULATION SPEC. WITHIN THE UFMEA, INADVERTENT SHOCK AND PATIENT BURN HAVE BEEN IDENTIFIED AS FAILURE EFFECTS FOR VARIOUS REASONS. PROCESS STEPS SUCH AS PREPPING THE SKIN SITE CORRECTLY, MAKING SURE THE SITE IS CLEAN AND DRY AND APPLYING THE ELECTRODE FIRMLY TO PATIENT'S SKIN ARE ALL PROCESS STEPS THAT USERS SHOULD ACCOUNT FOR WHILE APPLYING THE DEFIBRILLATOR PADS. IN ORDER TO MITIGATE RISK, INSTRUCTIONS FOR USE WERE COMPARED AGAINST OEM PRODUCT INSTRUCTIONS AND INSTRUCTIONS ARE AVAILABLE ON THE PADS AS WELL AS IN MULTIPLE LANGUAGES. BASED ON THE RISK REVIEW, AN INVESTIGATION INTO THE RAW MATERIAL CONFORMANCE AS WELL AS COMPLIANCE OF THE FINISHED DEVICE MEETING ALL SPECIFICATIONS AS DESIGNED. THE LOT WAS MANUFACTURED ON 10/3/2022 FOR (B)(4) PACKAGES. ALL PADS ARE 100% VERIFIED FOR CONTINUITY AND POLARITY IN PROCESS. THERE WERE NO REJECTS NOTED. THE SINGLE LOT REPRESENTATIVE SAMPLE WAS TESTED AND MET SPECIFICATIONS. THE REPORT WAS WITHIN 2 STANDARD DEVIATIONS OF THE HISTORICAL AVERAGE. THE RAW MATERIALS DID NOT HAVE ANY NON-CONFORMITIES FOR THE BASE ASSEMBLIES OR CONNECTOR WIRES. THE 3 LOTS OF CONDUCTIVE HYDROGEL USED IN PRODUCTION PASSED INTERNAL ADHESION SPECIFICATIONS WITH RESULTS OF (B)(4) GM/IN. THE AVERAGE ADHESION FROM 10/2019 - PRESENT IS (B)(4) GM/IN. THIS ADHESION TESTING IS PERFORMED PRIOR TO THE RELEASE OF THE PRODUCT FOR USE. THE 2 LOTS OF (B)(4) CONDUCTOR PLATES WERE RELEASED WITH NO ASSOCIATED NON-CONFORMANCES. A TREND REPORT SHOWS THIS IS THE 5TH COMPLAINT FOR THIS ISSUE UNDER THE C100 PART DESCRIPTION, 9TH OVERALL COMPLAINT FOR THIS ISSUE AND THE GENERIC FAMILY AND 12 COMPLAINTS FOR THIS ISSUE AND ALL DEFIB PRODUCTS (INCLUDING THIS COMPLAINT). DIRECTOR OF MARKETING STATED THERE HAVE BEEN APPROXIMATELY (B)(4) DEFIB PADS SOLD IN 10 YEARS. BASED ON THOSE NUMBERS, IT WAS DETERMINED APPROXIMATELY (B)(4) PADS HAVE BEEN SOLD BETWEEN JAN 2019 AND DEC 2022. THE COMPLAINT RATE FOR SPARKING / ARCING WOULD BE (B)(4) FOR ALL PRODUCT LINES. A REVIEW OF THESE 12 COMPLAINTS (INCLUDING THIS COMPLAINT) FOUND THERE WERE 2 COMPLAINTS WHERE THE ARC OCCURRED AFTER THE 2ND SHOCK, 2 COMPLAINTS WHERE THE STAFF STATED THEY BELIEVED THERE WAS POOR PAD CONTACT, 5 COMPLAINTS WHERE THERE WERE NOTED SKIN CONDITIONS (SUCH AS DRY SKIN, DIAPHORETIC SKIN) OR THE PATIENT WAS NOT PREPPED / SKIN WAS HAIRY, 1 COMPLAINT WHERE THE PADS WERE USED OUTSIDE OF THE INTENDED SCOPE (USERS PERFORMED MULTIPLE SHOCKS ON MANNEQUINS), AND 2 COMPLAINTS (INCLUDING THIS COMPLAINT) WHERE THERE WERE NO NOTED POTENTIAL CONTRIBUTING FACTORS. A REVIEW OF MAUDE REPORTS SUBMITTED TO THE FDA INDICATES COMPETITOR PADS EXPERIENCE SIMILAR FAILURE MODES OF SPARKING AND ARCING. SINCE JANUARY 2019 THERE HAS BEEN 141 REPORTS SUBMITTED FOR SPARKING OR ARCING FROM VARIOUS MANUFACTURERS. A REVIEW OF THE OEM ZOLL UNIT USER MANUAL (R-SERIES) WAS ALSO COMPLETED. WITHIN THE MANUAL IT STATES AS PART OF OPERATOR SAFETY THAT R-SERIES PRODUCTS SHOULD NOT BE USED IN THE PRESENCE OF OXYGEN-RICH ATMOSPHERES, FLAMMABLE ANESTHETICS, OR OTHER FLAMMABLE AGENTS. PER THE MEDWATCH REPORT PROVIDED TO NMT, THE PATIENT WAS WEARING A NON-REBREATHER MASK WITH OXYGEN SATURATION OF 90%. ON CARDIOVERTING THE PATIENT, THERE WAS ELECTRICAL ARCING ALONG THE RADIOTRANSPARENT DEFIBRILLATION ELECTRODE, WHICH CAUSED A FIRE THAT REACHED THE PATIENT'S FACE.

    Additional Manufacturer Narrative · 0

    BASED ON THE RISK REVIEW, AN INVESTIGATION INTO THE RAW MATERIAL CONFORMANCE AS WELL AS COMPLIANCE OF THE FINISHED DEVICE MEETING ALL SPECIFICATIONS AS DESIGNED. A REVIEW OF THE LOT DHR SHOWS NO REJECTIONS AND NO NONCONFORMANCES WITH RAW MATERIAL LOTS USED WITH NO DEVIATIONS ISSUED FOR THE PROCESS. ALL TESTING BASED WITH NO ANOMALIES. DEVICE WAS NOT AVAILABLE FOR RETURN SO NO FURTHER INVESTIGATION CAN BE PROVIDED.

    Description of Event or Problem · 0

    PHYSICIAN WAS CALLED TO PATIENT'S ROOM DUE TO NEW ONSET ATRIAL FIBRILLATION. THE PATIENT WAS WEARING A NON-REBREATHER MASK WITH OXYGEN SATURATION OF 90%. ON CARDIOVERTING THE PATIENT, THERE WAS ELECTRICAL ARCING ALONG THE RADIOTRANSPARENT DEFIBRILLATION ELECTRODE, WHICH CAUSED A FIRE THAT REACHED THE PATIENT'S FACE. THE NON-REBREATHER MASK WAS REMOVED FROM THE PATIENT'S FACE, AND THE FIRE WAS EXTINGUISHED. THE PATIENT SUFFERED WHAT APPEARED TO BE A SECOND DEGREE BURNS TO THE UPPER CHEST AND LOWER FACE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT FOR FURTHER MANAGEMENT. THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION. BRONCHOSCOPY WAS PERFORMED, WHICH SHOWER THIN SECRETIONS, NO CHARRING OR DISCOLORING IN THE AIRWAY. THE PATIENT WAS TRANSFERRED TO A BURN CENTER.

    Description of Event or Problem · 0

    PHYSICIAN WAS CALLED TO PATIENT'S ROOM DUE TO NEW ONSET ATRIAL FIBRILLATION. THE PATIENT WAS WEARING A NON-REBREATHER MASK WITH OXYGEN SATURATION OF 90%. ON CARDIOVERTING THE PATIENT, THERE WAS ELECTRICAL ARCING ALONG THE RADIOTRANSPARENT DEFIBRILLATION ELECTRODE, WHICH CAUSED A FIRE THAT REACHED THE PATIENT'S FACE. THE NON-REBREATHER MASK WAS REMOVED FROM THE PATIENT'S FACE, AND THE FIRE WAS EXTINGUISHED. THE PATIENT SUFFERED WHAT APPEARED TO BE A SECOND DEGREE BURNS TO THE UPPER CHEST AND LOWER FACE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT FOR FURTHER MANAGEMENT. THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION. BRONCHOSCOPY WAS PERFORMED, WHICH SHOWER THIN SECRETIONS, NO CHARRING OR DISCOLORING IN THE AIRWAY. THE PATIENT WAS TRANSFERRED TO A BURN CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200092 HEARTSYNC BY NISSHA MEDICAL DEFIBRILLATOR PAD MKJ GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES C100AC-ZOLL Y093022-02

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Life Threatening