BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY

    MDR report key: 14795736 · Received June 23, 2022

    Report

    Report Number
    0003015876-2022-01300
    Event Type
    Death
    Date Received
    June 23, 2022
    Date of Event
    May 25, 2022
    Report Date
    January 20, 2023
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    DRX
    UDI-DI
    00883873871690
    PMA / PMN Number
    K943301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CLINICAL REVIEW COMPLETED BY STRYKER CONCLUDED IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED OUTCOME. THERE IS INSUFFICIENT DATA WITHIN THE FILE TO DETERMINE THE IMPACT OF THE DEVICE USE. REVIEW OF THE PCO FILE REVEALS TWO INTERVALS, 9:57:09-9:57:22 AND 9:59:55-10:00:24, WHERE CPR STOPPED AND SIMULTANEOUSLY, LEAD-OFF OCCURS. NO ECG WAS AVAILABLE DURING THOSE PERIODS TO ANALYZE. BECAUSE THE ECG WAS UNAVAILABLE DURING THOSE TIMES, IT IS UNKNOWN IF THE PATIENT WAS IN A SHOCKABLE RHYTHM DURING THESE DURATIONS. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    STRYKER EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. AFTER COMPLETING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY TWICE DURING PATIENT USE. THE CUSTOMER ADVISED AFTER THE DEVICE CHARGED THERE WAS A DISCONNECT BETWEEN THERAPY CABLE AND THERAPY PADS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT IS DECEASED. IT IS UNKNOWN IF THE DEVICE DID OR DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY TWICE DURING PATIENT USE. THE CUSTOMER ADVISED AFTER THE DEVICE CHARGED THERE WAS A DISCONNECT BETWEEN THERAPY CABLE AND THERAPY PADS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT IS DECEASED. IT IS UNKNOWN IF THE DEVICE DID OR DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455179 QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY ELECTRODE, ELECTROCARDIOGRAPH DRX PHYSIO-CONTROL, INC. - 3015876 99577 203833 00883873871690

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MKJ,SN 48508778.