Xper Information Management and Flex Cardio Physiomonitoring Systems

• • Ongoing Z-1517-2021 FDA Class II ·initiated 29 Mar 2021

  Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor

• • Ongoing Z-2115-2018 FDA Class II ·initiated 20 Nov 2017

  While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.

• • Terminated Z-0614-2019 FDA Class II ·initiated 15 Nov 2018 ·on shared 510(k) K101571

  There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.

• • Completed Z-0462-2019 FDA Class II ·initiated 24 Sep 2018 ·on shared 510(k) K101571

  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

• • Terminated Z-3192-2018 FDA Class II ·initiated 3 Aug 2018

  Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.

• • Terminated Z-0263-2018 FDA Class II ·initiated 18 Aug 2017

  Intermittent communication between the host system and the FlexCardio

• • Terminated Z-0082-2018 FDA Class II ·initiated 11 Aug 2017

  Intermittent communication between the host system and the Flex Cardio

• • Terminated Z-2760-2016 FDA Class II ·initiated 19 Oct 2015

  Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K101571 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Calysto Series IV Patient Care Monitors and Central Station and ECG Management System

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  FDA 510(k) K033030 Active Cleared 24 Feb 2004

• Witt Biomedical Series II-Ep

  Class II

  FDA 510(k) K923054 Active Cleared 25 Feb 1993

• Calysto Series IV Physio-Monitoring and Information System

  Class II

  FDA 510(k) K063547 Active Cleared 21 Dec 2006

• Witt Biomedical Vx-80

  Class II

  FDA 510(k) K880258 Active Cleared 16 Jun 1988

• Image IV DICOM Image Archival PACS Network

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  FDA 510(k) K010058 Active Cleared 21 Mar 2001

• Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units

  Class II

  FDA 510(k) K973474 Active Cleared 13 Mar 1998

See all devices from Witt Biomedical Corp →