BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO

    MDR report key: 10215154 · Received June 30, 2020

    Report

    Report Number
    0003015876-2020-00819
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    May 15, 2020
    Report Date
    October 12, 2021
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    DRX
    UDI-DI
    00883873784969
    PMA / PMN Number
    K943301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 CONCOMITANT PRODUCTS DESCRIPTION OF THE INITIAL MEDWATCH REPORT INDICATES: BLANK SECTION D10 CONCOMITANT PRODUCTS DESCRIPTION OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ, (B)(6).

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED ISSUE. PHYSIO IDENTIFIED THAT THE ECG LEADS AND THERAPY CABLE WERE PAST EXPIRY. OUT OF DATE CABLES CAN BE A POSSIBLE CAUSE FOR THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY COULD NOT OBTAIN AN ECG ON THEIR LIFEPAK 20E DEVICE AND THERAPY CABLE ACCESSORY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY COULD NOT OBTAIN AN ECG ON THEIR LIFEPAK 20E DEVICE AND THERAPY CABLE ACCESSORY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED PHYSIO-CONTROL WITH THE AVAILABLE PATIENT INFORMATION. PHYSIO-CONTROL 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY COULD NOT OBTAIN AN ECG ON THEIR LIFEPAK 20E DEVICE AND THERAPY CABLE ACCESSORY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676879 QUIK-COMBO ELECTRODE, ELECTROCARDIOGRAPH DRX PHYSIO-CONTROL, INC. - 3015876 11996 930842 00883873784969

    Patients

    Seq Age Sex Outcome Treatment
    1 LIFEPAK® 20E DEFIBRILLATOR/MONITOR,MKJ,(B)(6).