z230

2026-05-27 15:27:38 +02:00
parent 23aa4b7fe7
commit 93de82256a
50 changed files with 17314 additions and 18 deletions
@@ -0,0 +1,107 @@
+{
+  "form_id": "461",
+  "patient_code": "CZ1-01",
+  "listing_cells": [
+    "CZ1-01",
+    "Male",
+    "Subject",
+    "16/02/2024",
+    "28/02/2024",
+    "17/04/2024",
+    "CZ1 - Fakultní Thomayerova nemocnice",
+    "DD",
+    "Device Deficiency",
+    "0",
+    "0",
+    "30",
+    "",
+    "",
+    "",
+    "23/02/2025",
+    "Accepted",
+    "",
+    "",
+    "0",
+    "100",
+    "0",
+    "",
+    "",
+    "1",
+    "Open",
+    ""
+  ],
+  "fields": [
+    {
+      "key": "Date of Onset",
+      "value": "23/02/2025",
+      "valueClass": "valeur DTEONSET"
+    },
+    {
+      "key": "Date device deficiency discovered by site",
+      "value": "04/03/2025",
+      "valueClass": "valeur DTEDEVIC"
+    },
+    {
+      "key": "Title of device deficiency",
+      "value": null,
+      "valueClass": ""
+    },
+    {
+      "key": "1 - Type of Device Deficiency",
+      "value": "Malfunction (failure of device to operate as intended when used per IFU and protocol)",
+      "valueClass": "valeur "
+    },
+    {
+      "key": "Specify other type of device deficiency",
+      "value": null,
+      "valueClass": ""
+    },
+    {
+      "key": "2 - Description of Event",
+      "value": "Patient reported to site device malfunction. Device switched to emergency regime and kept being permanently open. It is not possible to control device. The sponsor informed abou the deficiency immediately. Patient has no pain, no urine retention, as per X-ray, positioning of control unit and cuff is correct.",
+      "valueClass": "valeur DESC"
+    },
+    {
+      "key": "3 - Information about Device(s) (name, lot and serial number)",
+      "value": "Remote control 052300185, control unit 210011, cuff 22-0224",
+      "valueClass": "valeur INFO"
+    },
+    {
+      "key": "4 - Consequence of Device Deficiency",
+      "value": "Led to adverse event",
+      "valueClass": "valeur "
+    },
+    {
+      "key": "Lead to AE number",
+      "value": null,
+      "valueClass": ""
+    },
+    {
+      "key": "Action(s) taken",
+      "value": "Other",
+      "valueClass": "valeur "
+    },
+    {
+      "key": "If other action(s), specify",
+      "value": "Implementation of the new sofware leading to continence, time to activation emergency regime increased from 8 to 12hours",
+      "valueClass": "valeur ACTIONP"
+    },
+    {
+      "key": "Event Outcome",
+      "value": "Resolved without Sequelae",
+      "valueClass": "valeur "
+    },
+    {
+      "key": "Event End Date",
+      "value": "07/04/2025",
+      "valueClass": "valeur DTEEND"
+    }
+  ],
+  "table_structure": [
+    {
+      "tableIndex": 0,
+      "rowCount": 0,
+      "rows": []
+    }
+  ]
+}