BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION X SERIES

    MDR report key: 10792679 · Received November 4, 2020

    Report

    Report Number
    MW5097666
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 2, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CPR ADVANCED AIRWAYS WAS INSERTED IN PATIENT. PATIENT WAS ON DEFIB PADS CONNECTED TO MONITOR, AND MONITOR HAD BEEN TURNED ON AND READING PATIENT CARDIAC RHYTHM FOR 4-5 MINUTES. MONITOR HAD BEEN TURNED ON AND FUNCTIONING FOR A FEW MINUTES WITHOUT ANY FAULTS OR ISSUES BEING DISPLAYED ON SCREEN. AFTER INSERTION OF AIRWAY DEVICE, ETCO2 MONITORING WAS ATTEMPTED PER PROTOCOL. AFTER CONNECTING ETCO2 ADAPTER TO MONITOR AND PUSHING ETCO2 BUTTON ON MONITOR THE MONITOR STATES THAT THERE IS AN ERROR WITH THE ETCO2 MONITORING AND SERVICING IS REQUIRED. WAS UNABLE TO USE ETCO2 MONITORING TO MONITOR QUALITY OF CPR, AIRWAY PLACEMENT, OR PATIENT CONDITION THROUGHOUT CPR EVENT. THE MONITOR WAS TURNED ON AND A TEST SHOCK PERFORMED PER PROTOCOL AT THE START OF THE SHIFT AND THE MONITOR GAVE NO INDICATION THAT ANY OF THE FUNCTIONS OF THE MONITOR WERE NOT FUNCTIONING PROPERLY. MONITOR WAS TURNED IN TO EMS CHIEF, AND IS NOT AVAILABLE AT THIS TIME TO GATHER SERIAL NUMBER. THOUGH, IF NECESSARY TO TRACK DOWN IT HAS AN ASSET NUMBER USED BY THIS EMS AGENCY. THE ASSET NUMBER IS 20423. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247866 ZOLL MEDICAL CORPORATION X SERIES MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) DRT ZOLL MEDICAL CORPORATION XSCP-1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other