Device product
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Z-0462-2019
Product summary
- Event
- Event 81092
- Status
- Completed
- Classification
- Class II
- Quantity
- 76 units
- Official record key
device-enforcement:Z-0462-2019
Official wording
Reason: The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
Code information: Model Number 453564669081; System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092), US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096),
Distribution pattern: Distributed to the Netherlands
Derived failure modes
-
Unknown
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard