BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADPRO:AD;RTRANS EL/LW, 12X7

    MDR report key: 15563392 · Received October 7, 2022

    Report

    Report Number
    1320894-2022-00203
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 31, 2022
    Manufacturer
    KATECHO, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K014209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    CORRECTION: G4 COMBINATION PRODUCT WAS CHANGED FROM YES TO NO. ADDITIONAL 510K: P200004 MANUFACTURER NARRATIVE: REPORTED EVENT IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND A TOTAL OF 3 EVENTS INVOLVING A TOTAL OF 3 DEVICES FOR THIS LOT NUMBER. A DEVICE HISTORY RECORD WAS REQUESTED AND TO DATE, A RESPONSE WAS NOT RECEIVED; THEREFORE, A REVIEW CANNOT BE CONDUCTED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 15 REPORTS, REGARDING 16 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 2,689,930 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.000006. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INSPECT MULTI-FUNCTION ELECTRODE FOR DAMAGE, WEAR AND LOOSE CONNECTIONS PRIOR TO USE. DISCARD IF ANY DAMAGE OR WEAR IS FOUND. DO NOT APPLY MULTIFUNCTION ELECTRODES OVER BROKEN SKIN. DO NOT APPLY ANY SUBSTANCE TO THE SKIN SURFACE THAT WILL LEAVE A RESIDUE (E.G. LOTIONS, OILS, ETC.). THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M-C, PADPRO: AD;RTRANS EL/LW, 12X7 WAS BEING USED ON (B)(6) 2022 DURING A DEFIBRILLATION PROCEDURE AND THE ¿3 DIFFERENT PATIENTS RECEIVED WHAT APPEARED TO BE MILD BURNS WHERE THE DEFIB PADS WERE PLACED DURING THE PROCEDURES. NO OVERLYING BODY HAIR WAS PRESENT DURING DEFIBRILLATION.¿. THE PROCEDURE WAS COMPLETED WITH MEDTRONIC/STRYKER PHYSIO PADS. THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT ¿THE SITE WHERE THE PAD WAS APPLIED WAS SHAVED AND DRY WHEN THE PAD WAS APPLIED. THE PAD WAS FULLY ADHERED TO THE PATIENT AND THERE WERE NO AIR POCKETS OR "TENTING" OF THE APPLIED PAD.¿. THE DEGREE OF BURN IS NOT KNOWN. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO PATIENT.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M-C, PADPRO:AD;RTRANS EL/LW, 12X7 WAS BEING USED ON 19SEP22 DURING A DEFIBRILLATION PROCEDURE AND THE ¿3 DIFFERENT PATIENTS RECEIVED WHAT APPEARED TO BE MILD BURNS WHERE THE DEFIB PADS WERE PLACED DURING THE PROCEDURES. NO OVERLYING BODY HAIR WAS PRESENT DURING DEFIBRILLATION.¿. THE PROCEDURE WAS COMPLETED WITH MEDTRONIC/STRYKER PHYSIO PADS. THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT ¿THE SITE WHERE THE PAD WAS APPLIED WAS SHAVED AND DRY WHEN THE PAD WAS APPLIED. THE PAD WAS FULLY ADHERED TO THE PATIENT AND THERE WERE NO AIR POCKETS OR "TENTING" OF THE APPLIED PAD.¿ THE DEGREE OF BURN IS NOT KNOWN. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505541 PADPRO:AD;RTRANS EL/LW, 12X7 MKJ - AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ KATECHO, INC. Y08112207

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other MEDTRONIC/STRYKER PHYSIO PADS.| MEDTRONIC/STRYKER PHYSIO PADS.