BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FYSICON QMAPP

    MDR report key: 14014710 · Received April 4, 2022

    Report

    Report Number
    MW5108749
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    November 16, 2021
    Report Date
    March 31, 2022
    Manufacturer
    FYSICON BV
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN INTERNAL RECORDS REVIEW FOLLOWING AN INCIDENT THAT WAS REPORTED ON (B)(6) 2022 TO THE FDA MEDWATCH PROGRAM INVOLVING THE FYSICON QMAPP HEMODYNAMIC MONITORING SYSTEM, IT WAS DISCOVERED THAT 3 ADDITIONAL SIMILAR EVENTS HAD OCCURRED ON THIS SAME FYSICON QMAPP SYSTEM IN OTHER CATH LAB ROOMS. IN EACH OF THE EVENTS, THE ECG, AND PLETH WAVEFORMS WOULD SHOW AS A FLAT LINE AND NO NIBP, SPO2, OR ETCO2 VALUES APPEARED ON THE LIVE HEMODYNAMIC MONITORING SCREEN WHEN A PATIENT WAS CONNECTED TO THE SYSTEM. THE SYSTEM DID DISPLAY A HR VALUE BUT NO QRS WAVEFORM WAS PRESENT. A REBOOT OF THE SYSTEM AND/OR RESTARTING OF THE FYSICON QMAPP SYSTEM RESOLVED THE ISSUES. THE SEVERITY OF THE PATIENTS WERE NOT AS CRITICAL AS THE STEMI EVENT THAT OCCURRED ON (B)(6)2202 AND WHICH WAS PREVIOUSLY REPORTED TO THE MEDWATCH PROGRAM ON THIS SAME FYSICON QMAPP SYSTEM. THE 3 ADDITIONAL EVENTS OCCURRED ON THREE SEPARATE FYSICON QMAPP SYSTEMS ON (B)(6) 2021, (B)(6) 2022, AND (B)(6) 2022. NO USER HARM OCCURRED DURING THESE EVENTS DUE TO ADDITIONAL MONITORING BEING AVAILABLE, IE. AN EXTERNAL DEFIBRILLATOR MONITOR THAT WAS ATTACHED TO THE PATIENT. SYSTEM MODEL NUMBER ON ALL EVENTS (B)(4) (QMAPP HEMO REPORTING CPU) SN#(B)(4). RESPECTIVELY IN REFERENCE TO THE DATES LISTED ABOVE. FDA SAFETY REPORT ID#:(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440293 FYSICON QMAPP MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI FYSICON BV 01076010
    1440294 FYSICON QMAPP MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI FYSICON BV
    2339434 FYSICON QMAPP MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI FYSICON BV

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other| L