Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2010 Rev DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884838083820), received between Nov 19, 2019 and May 10, 2023 — classified as 1 death, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 29, 2021Open, Classified

   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

   Z-1517-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF PATIENT CODING, WOULD LIKE SOMEONE TO LOOK AT PATIENT LOGS. THE CUSTOMER INDICATED PATIENT HARM; HOWEVER, NO DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PATIENT STATUS AND EVENT DETAILS ARE UNKNOWN. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED WITH THE LOGS AND THERE WAS NO RELEVANT DEVICE DATA FOUND DURING THE TIME FRAME OF THE ALLEGED FAILURE. IN ADDITION, THE RSE IDENTIFIED THE DEVICE WAS NOT BEING SHUTDOWN IN ORDER TO PREVENT FAILURES DURING CASES AND THAT THERE HAS NOT BEEN ANY PREVENTATIVE MAINTENANCE (PM) PERFORMED ON DEVICES. THE CUSTOMER WAS PROVIDED WITH DOCUMENTATION ON THESE PROCEDURES SO THEY CAN PERFORM PM WORK, AND THE STAFF WAS INSTRUCTED THAT THESE DEVICES NEED TO BE SHUTDOWN AND RESTARTED DAILY BEFORE CASES ARE PERFORMED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT. THE EVENT DETAILS WERE REVIEWED BY A PHILIPS SR. PRODUCT SUPPORT ENGINEER WHO STATED THE LIKELY CAUSE OF THE EVENT IS THE FLEX CARDIO WAS OVER ENERGIZED PAST THE BOUNDS OF OUR SPECIFICATIONS.

  Patient problems: Cardiac Arrest

  MAUDE report 16904627 ↗
• InjuryApr 7, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF PATIENT CODING, WOULD LIKE SOMEONE TO LOOK AT PATIENT LOGS. THE CUSTOMER INDICATED PATIENT HARM; HOWEVER, NO DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PATIENT STATUS AND EVENT DETAILS ARE UNKNOWN. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED WITH THE LOGS AND THERE WAS NO RELEVANT DEVICE DATA FOUND DURING THE TIME FRAME OF THE ALLEGED FAILURE. IN ADDITION, THE RSE IDENTIFIED THE DEVICE WAS NOT BEING SHUTDOWN IN ORDER TO PREVENT FAILURES DURING CASES AND THAT THERE HAS NOT BEEN ANY PREVENTATIVE MAINTENANCE (PM) PERFORMED ON DEVICES. THE CUSTOMER WAS PROVIDED WITH DOCUMENTATION ON THESE PROCEDURES SO THEY CAN PERFORM PM WORK, AND THE STAFF WAS INSTRUCTED THAT THESE DEVICES NEED TO BE SHUTDOWN AND RESTARTED DAILY BEFORE CASES ARE PERFORMED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT. THE EVENT DETAILS WERE REVIEWED BY A PHILIPS SR. PRODUCT SUPPORT ENGINEER WHO STATED THE LIKELY CAUSE OF THE EVENT IS THE FLEX CARDIO WAS OVER ENERGIZED PAST THE BOUNDS OF OUR SPECIFICATIONS.

  Patient problems: Cardiac Arrest

  MAUDE report 16700356 ↗
• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED A PATIENT ON THE TABLE HAVING A STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) AND THERE IS NO ECG. CUSTOMER STATED THAT ALL OTHER VITALS ARE FINE. STAFF REPORTEDLY IS USING A DEFIBRILLATOR TO MONITOR THE PATIENT'S ECG. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15350623 ↗
• MalfunctionJul 25, 2022Measurement System Incompatibility; Application Program Freezes or Fails to Launch; Measurement System Incompatibility; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED MONITORING DISRUPTIONS DURING DEFIBRILLATION. WE ARE IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; Shock

  MAUDE report 15095641 ↗
• InjuryMay 16, 2022Failure to Deliver Shock/Stimulation; Measurement System Incompatibility; Failure to Deliver Shock/Stimulation; Measurement System Incompatibility

  THE CUSTOMER REPORTED THAT, DURING A PATIENT PROCEDURE ON (B)(6) 2022 AT AROUND 17:30 THE PATIENT REQUIRED DEFIBRILLATION. THE CUSTOMER REPORTED THAT THE FIRST SHOCK OF 200 VOLTS WAS OK, BUT THE SECOND SHOCK AT 360 VOLTS CAUSED THE HEMO DEVICE TO BECOME UNRESPONSIVE. THE CUSTOMER REPORTEDLY WAITED FOR THE SIGNAL TO RETURN AND AFTER THIRTY (30) SECONDS REBOOTED THE FC2010 DEVICE TO RECOVER. THE CUSTOMER REPORTS OVER ONE (1) MINUTE OF DOWNTIME. REMOTE SUPPORT CONFIRMED WITH THE CUSTOMER THAT THE ECG, P1 (PRESSURE CHANNEL 1), AND NIBP (NON-INVASIVE BLOOD PRESSURE) WERE CONNECTED TO PATIENT. ACCORDING TO REMOTE SUPPORT, THESE ARE DEFIB-PROOF INPUTS AND SHOULD ONLY EXPERIENCE 5 SECONDS DELAY IN SIGNAL AFTER DEFIB. IN THIS CASE, NORMAL OPERATING MODE DID NOT RETURN. AVAILABLE INFORMATION SUGGESTS THAT THE PATIENT'S CONDITION AND/OR PROCEDURE WAS ONE IN WHICH REQUIRED THE PATIENT TO BE DEFIBRILLATED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED BY THE CUSTOMER AS A RESULT OF THIS INCIDENT. ONSITE SUPPORT HAS BEEN DISPATCHED TO FURTHER EVALUATE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406490 ↗
• MalfunctionMar 29, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE ECG WOULD FREEZE AND THEN DISAPPEAR. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939140 ↗
• MalfunctionJul 15, 2021Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT OCCASIONALLY PRESSURE READINGS DO NOT CHANGE. THE PRESSURE WAVEFORM IS CORRECT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174722 ↗
• MalfunctionMay 14, 2021No Display/Image; Incorrect Measurement; No Display/Image; Incorrect Measurement

  THE CUSTOMER REPORTED FAILURES OF THE MEASUREMENT. THE VALUES ARE NOT DISPLAYED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826202 ↗
• MalfunctionMar 9, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PROBLEMS WITH NBP MEASUREMENT. DURING OPERATION, THE MONITOR SHOWING ECG SIGNALS FROZE. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445264 ↗
• MalfunctionDec 17, 2020Operating System Becomes Nonfunctional

  THE CUSTOMER REPORTED NIBP MEASUREMENT FROZE THREE TIMES. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029379 ↗
• DeathOct 2, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED TO PHILIPS THAT, ON A PATIENT WITH AN EXTERNAL STIMULATION, THE ECG WAVES ARE VERY SPIKEY, AND DURING A SHORT PERIOD DISAPPEARED. THE PATIENT PASSED AWAY.

  Patient problems: Death

  MAUDE report 10623561 ↗
• MalfunctionJun 15, 2020Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) IS NOT UPDATING. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153229 ↗
• MalfunctionNov 19, 2019Defective Device

  THE CUSTOMER REPORTED THAT, THE CATH LAB RECEIVED A PATIENT FROM THE EMERGENCY DEPARTMENT IN EMERGENT CARDIAC DISTRESS WITH A DIAGNOSED ST ELEVATED MYOCARDIAL INFARCTION = HEART ATTACK IN PROCESS. ACCORDING TO THE CUSTOMER, AT THE VERY BEGINNING OF THE PROCEDURE, THE CLINICAL TEAM WAS NOT ABLE TO ZERO THE INVASIVE PRESSURE CHANNELS P1 OR P2 THAT RECEIVE THE PATIENT'S INVASIVE PRESSURE THAT IS PRESENTED BY THE BACK-PLATE AND PRESSURE CAPSULES OF THE BRACCO ACIST CVI POWER INJECTIONS SYSTEM. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345029 ↗