BEUDAMED
    FDA Adverse Event Death Summary report: N

    MFG: CRITICARE SYSTEMS INC., MODEL: NGENUITY

    MDR report key: 8879804 · Received August 9, 2019

    Report

    Report Number
    3012238587-2019-10003
    Event Type
    Death
    Date Received
    August 9, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 3, 2019
    Manufacturer
    CRITICARE SYSTEMS INC,
    Product Code
    MHX
    PMA / PMN Number
    K030613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ON 5/3/2019 BY (B)(4): THE UNIT IN QUESTION IS A 7 YEAR OLD SYSTEM MANUFACTURED BY CRITICARE SYSTEMS, INC. A COMPANY WHICH IS NO LONGER IN BUSINESS. WE PURCHASED THE RIGHTS TO THE PRODUCT AND MANUFACTURE IT AS CRITICARE TECHNOLOGIES, INC. THERE IS NO INDICATION OR ALLEGATION THAT THE UNIT WAS NOT PROVIDING ACCURATE DATA. DR. (B)(6), WHO WAS PERFORMING THE PROCEDURE, STATED THAT HE DID NOT REMEMBER ANY ALARMS. PATIENT FAILED TO ROUSE FROM SEDATION. SPECIFIC INFORMATION ABOUT TYPE OF SEDATION USED, DURATION, AND SPECIFICS ABOUT THE ACTION TAKEN TO REVIVE PATIENT ARE UNKNOWN TO CRITICARE TECHNOLOGIES. AN INVESTIGATION OF THE UNIT WILL BE CONDUCTED ON 5/9/2019 AND THIS REPORT WILL BE UPDATED WITH ANY ADDITIONAL INFORMATION AND A COPY OF THE COMPLAINT INVESTIGATION AND ITS FINDINGS. THE UNIT IS SECURED IN QUARANTINE AS IT WAS RECEIVED AND WILL NOT BE OPENED UNTIL THE INVESTIGATION COMMENCES. THIS INVESTIGATION WILL INCLUDE, BUT NOT BE LIMITED TO, THE RETRIEVAL OF ANY INFORMATION IN THE UNIT RELATED TO ITS LAST USE AND A CHECK OF THE UNIT ALARMS. THERE IS OBVIOUS DAMAGE TO THE UNIT PACKAGING. THE SUMMARY FROM THIS TESTING TAKEN FROM PAGE 3 OF THE CAPA INVESTIGATION IS: COMPLAINT INVESTIGATION TESTING SUMMARY (MAY 10, 2019) THE TESTING INDICATED THAT THE PHYSIOLOGICAL PARAMETERS WERE IN CONFORMANCE FOR THE MONITOR SN (B)(4). AUDIBLE AND VISUAL ALARMS WERE FUNCTIONING NORMALLY. THERE WERE NO GENERAL PERFORMANCE ISSUES OBSERVED THAT WOULD HAVE INTERFERED WITH AUDIBLE AND VISUAL ALARM GENERATION. SEE TESTING CHECKLISTS. IT WAS NOTED DURING THE COMPLAINT INVESTIGATION TESTING ON MAY 10TH THAT THE TWO CHECKLIST INSTRUCTION STEPS FOR TESTING ST FILTERING DID NOT HAVE RANGE LIMITS INDICATED. ST MONITORING WAS NOT BEING CONDUCTED DURING THIS EVENT SUCH THAT IT IS NOT SIGNIFICANT TO THIS INVESTIGATION. FACTORY TESTING SUMMARY (MAY 13, 2019) AS PART OF THE CAPA INVESTIGATION THE MONITOR SN (B)(4) WAS TESTED AGAIN PER FACTORY PROTOCOLS. ALARM SILENCE AND ALARM SUSPEND FUNCTIONALITY WERE VERIFIED AGAIN AND FOUND TO BE PASSING. SPO2 FUNCTIONALITY AND SATURATION ACCURACY WAS VERIFIED AGAIN AND FOUND TO BE PASSING. THE ST FILTER TEST WAS VERIFIED AGAIN USING THE CTI FACTORY EQUIPMENT AND PASSED. THE NIBP PERFORMANCE WAS EXAMINED USING THE FACTORY CALIBRATION FIXTURE AND PASSED. BATTERY CHARGING WAS VERIFIED AND PASSED. THE CAPNOGRAPHY MODULE WAS VERIFIED AND PASSED CO2 CONCENTRATION ACCURACY TESTING. ALL PARAMETERS TESTED FOR MONITOR SN (B)(4) WERE FOUND TO BE PASSING. ON MAY 21, 2019 CAPA (B)(4) WAS CLOSED. THE ROOT CAUSE WAS NOT APPLICABLE AS NO PROBLEMS WERE FOUND WITH THE SYSTEM. AS A RESULT OF THIS FINDING NO ACTIONS WERE RECOMMENDED. CRITICARE TECHNOLOGIES HAS CONCLUDED THROUGH ITS TESTING AND ANALYSIS OF THE RETURNED UNIT THAT IT WAS FUNCTIONING NORMALLY AT THE TIME OF THE EVENT. ALL TESTING PERFORMED FAILED TO FIND ANY INDICATION OF ANY TYPE OF MALFUNCTION. DATA WAS CAPTURED BY THE DEVICE. THIS DATA INCLUDED DATA FROM THE EVENT. A REVIEW OF THE DATA CLEARLY SHOWS THE DEVICE TO BE IN A SOUND CONDITION. DR (B)(6) WAS NOTIFIED OF OUR FINDINGS AND GIVEN A SUMMARY. UNLESS FURTHER INFORMATION COMES TO LIGHT CRITICARE TECHNOLOGIES CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 DR (B)(6) CALLED (B)(4) CELL PHONE AT 10:20 AM. HE PROVIDED THE FOLLOWING INFORMATION. DR (B)(6) WAS THE DENTIST PERFORMING THE PROCEDURE. THE PROCEDURE WAS AN EXTRACTION. THE PATIENT WAS SEDATED USING AN UNKNOWN METHOD AND SUBSTANCE. PATIENT WAS UNDER SEDATION FOR 5-9 MINUTES. PATIENT HAD A SUDDEN DROP IN SPO2 SATURATION 5-9 MINUTES AFTER SEDATION. HE SAYS HE DOES NOT RECALL HEARING ALARMS AND STATED THAT DOESN'T RECALL DETAILS OF THE SCREEN AT THE TIME OF THE INCIDENT. DR (B)(6) FIRST ATTEMPTED TO ADJUST THE SPO2 SENSOR ON THE FINGER AND ATTEMPTED TO GET A NIBP MEASUREMENT. HE SAID THE PATIENT WAS CONNECTED TO THE MONITOR AT TIME OF DEATH. ON (B)(6) 2019 AT 10:37 AM DR. (B)(6) CALLED AGAIN AND ADDED THE FOLLOWING. WHEN THE PATIENT WAS NOT AROUSING HE ADDED THREE LEAD ECG USING CONMED PADS. HE SAID THE ORIGINAL CO2 READING WAS 8MMHG. HE SAID THAT NO CO2 APNEA ALARM WAS SOUNDING AT THE TIME OF THE INCIDENT AND THAT THE PATIENT HAD A NASAL HOOD AT THE TIME OF THE INCIDENT. HE SAID AT 9 MINUTES THE SPO2 PULSE RATE WAS 77BPM AND DROPPED TO 66BPM. WHEN HE GOT THE INITIAL ECG HEART RATE AT 14 MINUTES INTO THE PROCEDURE WAS 23BPM. THEN AT 17 MINUTES THE BPM WENT UP TO 30, AND AT 30 MINUTES WAS UP TO 79. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672264 MFG: CRITICARE SYSTEMS INC., MODEL: NGENUITY PATIENT MONITOR MHX CRITICARE SYSTEMS INC, 8100EP1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death UNAVAILABLE AT THIS TIME