IMPAX
Report
- Report Number
- 2249582-2025-00001
- Event Type
- Death
- Date Received
- March 31, 2025
- Date of Event
- March 12, 2025
- Report Date
- April 25, 2025
- Manufacturer
- AGFA HEALTHCARE N.V.
- Product Code
- LLZ
- UDI-DI
- 05400874000727
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- 501
Narratives
THE CUSTOMER STATED THAT THE 40-YEAR-OLD FEMALE PATIENT WAS FOUND IN CARDIOPULMONARY ARREST AT 5:00AM AT HOME AND WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE, ARRIVING AT THE EMERGENCY DEPARTMENT (ED) AT 5:50AM, ADMITTED IN CRITICAL, PRIORITY 1 STATUS. A CARDIAC ULTRASOUND AND ECG WERE PERFORMED IN THE ED UPON ARRIVAL. THE PATIENT'S HISTORY PROVIDED BY THE CUSTOMER IS: POORLY CONTROLLED ASTHMA/COPD, BRONCHOSPASM, PNEUMONIA, SMOKING AND OPIOID DEPENDENCE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND THE PATIENT'S CARDIAC RHYTHM RETURNED TO SINUS RHYTHM AT 6:09AM. THE PATIENT WAS INTUBATED AT 6:30AM. IN ADDITION TO THE ENDOTRACHEAL INTUBATION (ETI) AND CPR, THE CUSTOMER HAS CONFIRMED THAT THE FOLLOWING MEDICATIONS WERE ADMINISTERED PRIOR TO TRANSPORT TO THE RADIOLOGY DEPARTMENT: INTRAVENOUS (IV) EPINEPHRINE X2, IV FENTANYL, IV VERSED, IV KETAMINE, IV VENTOLIN, IV SOLUMEDROL, IV VANCOMYCIN, AND VENTOLIN (ROUTE OF ADMINISTRATION WAS NOT SHARED HOWEVER FOR MECHANICALLY VENTILATED PATIENTS, BASED ON CLINICAL EXPERIENCE, THE USUAL ROUTE OF ADMINISTRATION IS VIA NEBULIZER OR METERED DOSE INHALER (MDI)). THE PATIENT ARRIVED AT THE RADIOLOGY DEPARTMENT AT 7:40AM. THE CUSTOMER CONFIRMED THE PATIENT HAD BEEN STABILIZED IN THE ED BETWEEN 5:50AM AND 7:40AM, PRIOR TO TRANSPORT TO RADIOLOGY. A NON-CONTRAST BRAIN CT STUDY WAS ACQUIRED FOLLOWED BY CONTRAST-ENHANCED THORACO-ABDOMINOPELVIC CT ANGIOGRAPHY (CTA) WERE ACQUIRED AT 7:58AM WHILE IN THE RADIOLOGY DEPARTMENT. THE CLINICAL INFORMATION/REASON FOR STUDY WAS DOCUMENTED AS "CARDIO-RESPIRATORY ARREST. CAUSE? FIXED PUPILS. DISTENDED ABDOMEN. NORMAL HEART ULTRASOUND." THE CUSTOMER CONFIRMED THE PATIENT WAS ALIVE FOR BOTH STUDIES AND RETURNED TO THE ED AND VITAL SIGNS WERE RECORDED. PER THE LOGS COLLECTED BY AGFA SUPPORT, THE RADIOLOGIST, DR (B)(6), READING FROM A REMOTE HOME STATION, INITIALLY ATTEMPTED TO VIEW THE IMAGES AT 8:03AM, INSTEAD A "PROBLEM DOWNLOADING IMAGE, WILL ATTEMPT TO RETRY" ERROR MESSAGE DISPLAYED TO THE USER. THE IMAGES WERE CONFIRMED TO BE ACCESSIBLE ON THE MODALITY, HOWEVER, THE RADIOLOGIST DID NOT PROCEED WITH ALTERNATIVE DIAGNOSTIC STEPS AS HE WAS FOCUSED ON DISPLAYING THE IMAGES IN THE IMPAX CLIENT ON HIS HOME DIAGNOSTIC CONSOLE. THE RADIOLOGIST USER DECIDED TO RESTART THE HOME STATION WHICH TOOK APPROXIMATELY 4-5 MINUTES. THE LOGS CONFIRMED THAT THE IMAGES WERE SUCCESSFULLY VIEWED BY THE RADIOLOGIST AT 8:08AM, AND THE DICTATION WORKFLOW COMPLETED. THE PATIENT WAS TRANSFERRED TO THE ICU AT 8:15AM, AND A CHEST XRAY ACQUIRED AT 11:15AM. FOLLOWING A DISCUSSION WITH THE FAMILY, AS THE PATIENT WAS CONFIRMED TO BE BRAIN DEAD, THE PATIENT WAS PLACED IN COMFORT CARE AND EXTUBATED AT 9:15PM. THE PATIENT WAS PRONOUNCED DECEASED IN THE ICU WITH A TIME OF DEATH OF 10:28PM ON (B)(6) 2025. IT WAS REPORTED BY THE CUSTOMER THAT THE INABILITY TO VIEW THE IMAGES DURING THE EMERGENCY SITUATION CAUSED THEM "TO LOSE VALUABLE MINUTES IN MAKING THE DIAGNOSIS. THE CAUSE OF DEATH WAS CONFIRMED TO BE REFRACTORY BRONCHOSPASM DUE TO BILATERAL PNEUMONIA. SUMMARY: TAKING ALL FACTORS INTO CONSIDERATION, INCLUDING PATIENT HISTORY, CLINICAL PRESENTATION UPON ED ARRIVAL WITH FIXED PUPILS, DIAGNOSTIC IMAGING FINDINGS, MEDICAL MANAGEMENT PRE AND POST DIAGNOSTIC IMAGING ACQUISITION, AND CAUSE OF DEATH; BASED ON CLINICAL EXPERIENCE, AGFA HEALTHCARE BELIEVES THAT THE 5 MINUTE DELAY IN IMAGE VIEWING BY THE READING RADIOLOGIST DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. ALSO, AGFA'S RISK ANALYSIS INDICATES THAT THE POTENTIAL FOR HARM FALLS BELOW THE REPORTING THRESHOLD (THE DEVICE WOULD BE NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE ISSUE WERE TO RECUR). AS THE CUSTOMER SUBMITTED AN INCIDENT INVOLVING THE DEATH OF A PATIENT, AGFA HEALTHCARE DECIDED TO REPORT THIS INCIDENT REGARDLESS. SOFTWARE VERSION: 6.7.1 SU02; UDI-DI: (B)(4); BASIC UDI: (B)(4).
ON MARCH 12, 2025, A CUSTOMER REPORTED THE FOLLOWING INCIDENT TO AGFA HEALTHCARE THROUGH COMPLAINT (B)(4): A 40-YEAR-OLD FEMALE PATIENT ARRIVED IN THE EMERGENCY IN CARDIAC AND RESPIRATORY ARREST. WHEN THE RADIOLOGIST, READING FROM A REMOTE HOME STATION, ATTEMPTED TO VIEW THE IMAGES, AN ERROR MESSAGE 'PROBLEM DOWNLOADING IMAGE, WILL ATTEMPT TO RETRY" DISPLAYED AND COULD NOT VIEW THE CT AND CTA IMAGES. THE RADIOLOGIST USER RESTARTED THE WORKSTATION WHICH TOOK APPROXIMATELY 4-5 MINUTES AFTER WHICH THE IMAGES COULD BE SUCCESSFULLY VIEWED. THE CUSTOMER REPORTED THAT THE INABILITY TO VIEW THE IMAGES DURING THE EMERGENCY SITUATION CAUSED THEM TO LOSE VALUABLE MINUTES IN MAKING THE DIAGNOSIS. THE VIEWING ISSUE HAPPENED AROUND 8 AM AND THE PATIENT PASSED AWAY AT 10:25 PM LATER THAT DAY. SUMMARY: TAKING ALL FACTORS INTO CONSIDERATION, INCLUDING PATIENT HISTORY, CLINICAL PRESENTATION UPON ED ARRIVAL WITH FIXED PUPILS, DIAGNOSTIC IMAGING FINDINGS, MEDICAL MANAGEMENT PRE AND POST DIAGNOSTIC IMAGING ACQUISITION, AND CAUSE OF DEATH; BASED ON CLINICAL EXPERIENCE, AGFA HEALTHCARE BELIEVES THAT THE 5 MINUTE DELAY IN IMAGE VIEWING BY THE READING RADIOLOGIST DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. ALSO, AGFA'S RISK ANALYSIS INDICATES THAT THE POTENTIAL FOR HARM FALLS BELOW THE REPORTING THRESHOLD (THE DEVICE WOULD BE NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE ISSUE WERE TO RECUR). AS THE CUSTOMER SUBMITTED AN INCIDENT INVOLVING THE DEATH OF A PATIENT, AGFA HEALTHCARE DECIDED TO REPORT THIS INCIDENT REGARDLESS.
ON (B)(6) 2025, A CUSTOMER REPORTED THE FOLLOWING INCIDENT TO AGFA HEALTHCARE THROUGH COMPLAINT (B)(4): A 40-YEAR-OLD FEMALE PATIENT ARRIVED IN THE EMERGENCY IN CARDIAC AND RESPIRATORY ARREST. WHEN THE RADIOLOGIST, READING FROM A REMOTE HOME STATION, ATTEMPTED TO VIEW THE IMAGES, AN ERROR MESSAGE 'PROBLEM DOWNLOADING IMAGE, WILL ATTEMPT TO RETRY" DISPLAYED AND COULD NOT VIEW THE CT AND CTA IMAGES. THE RADIOLOGIST USER RESTARTED THE WORKSTATION WHICH TOOK APPROXIMATELY 4-5 MINUTES AFTER WHICH THE IMAGES COULD BE SUCCESSFULLY VIEWED. THE CUSTOMER REPORTED THAT THE INABILITY TO VIEW THE IMAGES DURING THE EMERGENCY SITUATION CAUSED THEM TO LOSE VALUABLE MINUTES IN MAKING THE DIAGNOSIS. THE VIEWING ISSUE HAPPENED AROUND 8 AM AND THE PATIENT PASSED AWAY AT 10:25 PM LATER THAT DAY. SUMMARY: TAKING ALL FACTORS INTO CONSIDERATION, INCLUDING PATIENT HISTORY, CLINICAL PRESENTATION UPON ED ARRIVAL WITH FIXED PUPILS, DIAGNOSTIC IMAGING FINDINGS, MEDICAL MANAGEMENT PRE AND POST DIAGNOSTIC IMAGING ACQUISITION, AND CAUSE OF DEATH; BASED ON CLINICAL EXPERIENCE, AGFA HEALTHCARE BELIEVES THAT THE 5 MINUTE DELAY IN IMAGE VIEWING BY THE READING RADIOLOGIST DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. ALSO, AGFA'S RISK ANALYSIS INDICATES THAT THE POTENTIAL FOR HARM FALLS BELOW THE REPORTING THRESHOLD (THE DEVICE WOULD BE NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE ISSUE WERE TO RECUR). AS THE CUSTOMER SUBMITTED AN INCIDENT INVOLVING THE DEATH OF A PATIENT, AGFA HEALTHCARE DECIDED TO REPORT THIS INCIDENT REGARDLESS. ROOT CAUSE OF 5 MINUTE DELAY: THE AGFA PERFORMED TECHNICAL INVESTIGATION DISCOVERED WHEN REVIEWING THE WORKFLOW MANAGER (WFM) SERVER LOGS AT THE SITE THAT TICKET EXPIRY ERRORS APPEARED. IT WAS CONFIRMED THAT THE WFM SERVER WAS BRIEFLY OUT OF SYNC, AS THE TIME WAS AHEAD BY APPROXIMATELY 80 SECONDS. THE TECHNICAL INVESTIGATION REVEALED THAT THE BRIEF DELAY IN IMAGE VIEWING OF 4 -5 MINUTES WAS CAUSED BY THE RADIOLOGIST'S DECISION TO RESTART THE HOME DIAGNOSTIC WORKSTATION WHEN THE IMAGES WERE NOT IMMEDIATELY AVAILABLE, DUE TO THE CONFIGURATION OF THE NTP SERVER AT TIME OF GO-LIVE ON (B)(6) 2025. NTP SERVER PROVIDES ACCURATE TIME INFORMATION TO OTHER DEVICES ON A NETWORK, ENSURING THAT ALL SYSTEMS MAINTAIN TIME SYNCHRONIZATION. THIS ISSUE IS NOT THE RESULT OF AN AGFA PRODUCT DEFECT. THIS TYPE OF SYNCHRONIZATION ISSUE IN THE WORKFLOW MANAGER IS RELATED TO A MISSED SERVER CONFIGURATION AT THIS PARTICULAR SITE AND NOT RELATED TO SOFTWARE/PRODUCT. CORRECTIVE ACTION: A CONFIGURATION CHANGE WAS COMPLETED ON (B)(6) 2025, TO ADDRESS THE TIME SYNC ISSUE. THE NTP SERVER WAS ADDED INTO THE ESX SERVER CONFIGURATION AT THE SITE AND THE NTPD SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165828 | IMPAX | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | LLZ | AGFA HEALTHCARE N.V. | 05400874000727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Death |