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CZ1 - Fakultní Thomayerova nemocnice
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CZ1-01
H Date of birth : 05/1955 / Center : CZ1 - Fakultní Thomayerova nemocnice
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4 Device Deficiency - 23/02/2025Device DeficiencyTitle of device deficiency
1 - Type of Device Deficiency
Malfunction (failure of device to operate as intended when used per IFU and protocol)
Specify other type of device deficiency
2 - Description of Event
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.
3 - Information about Device(s) (name, lot and serial number)
Remote control 052300185, control unit 210011, cuff 22-0224
4 - Consequence of Device Deficiency
Led to adverse event
Lead to AE number
Action(s) taken
Action(s) taken
Other
Other action(s)
If other action(s), specify
Implementation of the new sofware leading to continence, time to activation emergency regime increased from 8 to 12hours
Event Outcome
Event Outcome
Resolved without Sequelae
2025-03-12 11:21:35 : Created / Signed HanaFiserova Fiserová Hana
2025-03-12 11:22:22 : Modified HanaFiserova Fiserová Hana 2025-03-12 11:24:15 : Modified/ Signed HanaFiserova Fiserová Hana 2025-03-22 22:08:03 : Modified HanaFiserova Fiserová Hana 2025-04-17 10:11:55 : Modified HanaFiserova Fiserová Hana 2025-09-01 18:06:54 : Modified/ Signed HanaFiserova Fiserová Hana 2025-09-01 18:10:54 : Modified/ Accepted vbuzalka Buzalka Vladimir |
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