Xper Flex Cardio Physiomonitoring System FC 2010 (REF 453564243591)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00884838082113), received between Nov 20, 2018 and May 25, 2022 — classified as 2 deaths, 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (5 reports).

2 FDA recall records 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 ↗

2. Mar 14, 2018Terminated

   The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.

   Z-1867-2018 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• DeathMay 25, 2022Defibrillation/Stimulation Problem; Measurement System Incompatibility; Defibrillation/Stimulation Problem; Measurement System Incompatibility

  IT WAS REPORTED THAT USE OF A DEFIBRILLATOR WAS NECESSARY DURING THE CASE AND, AFTER DEFIBRILLATING THE PATIENT, THE ECG BECAME FLAT AND ALSO MONITORING OFF WAS DISPLAYED. A RESTART OF THE SYSTEM WAS NEEDED IN ORDER TO RESUME FUNCTION OF THE FLEX CARDIO. THE DEVICE WAS IN USE AT TIME OF EVENT AND WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER BEING TRANSFERRED TO THE ICCU.

  Patient problems: Insufficient Information

  MAUDE report 14495971 ↗
• MalfunctionApr 13, 2022Device Alarm System; Inappropriate Audible Prompt/Feedback; Device Alarm System; Inappropriate Audible Prompt/Feedback

  THE CUSTOMER REPORTED NO ACOUSTIC WARNING SOUND FOR THE BLOOD SATURATION EXISTS ANYMORE. 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 14105030 ↗
• MalfunctionMar 19, 2022Material Discolored; Failure to Power Up; Material Discolored; Failure to Power Up

  THE CUSTOMER REPORTED THAT THE FLEX CARDIO UNIT WILL NOT POWER ON. TROUBLESHOOTING PERFORMED BY THE BIOMED FOUND THAT WHERE THE POWER SUPPLY CONNECTS TO THE FLEX CARDIO DEVICE APPEARS TO HAVE BURN DAMAGE (SCORCH MARKS) ON THE DEVICE. THERE WAS NO MENTION OF SMOKE OR FLAMES. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824657 ↗
• MalfunctionNov 23, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED AN ERROR WHEN OPENING THE WAVEFORM AUDIO DEVICE DURING EXAMINATION. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859948 ↗
• MalfunctionOct 19, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) REPEATS THE SAME READING. 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 12658191 ↗
• MalfunctionSep 24, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED ISSUES WITH THE ECG PAUSING ON THE WORKSTATION AND ON THE BOOM SINCE RECENT SOFTWARE UPGRADE TO 1.5.19.0327. THIS HAS BEEN INTERPRETED TO MEAN THAT THE ECG SIGNAL WAS FROZEN OR NOT UPDATING DURING THIS TIME. 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 12527961 ↗
• MalfunctionSep 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ONSITE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT AFTER RELOADING THE SOFTWARE FOR AN UNRELATED ISSUE, THE ECG TRACES WOULD THEN SOMETIMES GO FAST OR ABNORMALLY SLOW (SWEEP SPEED). THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477427 ↗
• MalfunctionAug 31, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE MONITORING SCREEN FREEZES. 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 12394146 ↗
• DeathJun 3, 2021No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT, A CASE WAS IN PROGRESS AND THE VIDEO FROM THE HEMO (XPER) SYSTEM WENT BLANK ON THE FLEXVISION MONITOR. VIDEO WAS STILL VISIBLE IN THE CONTROL ROOM. PATIENT ON THE TABLE DECEASED.

  Patient problems: Cardiac Arrest

  MAUDE report 11930531 ↗
• MalfunctionMay 27, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE BOOM HEMO WAVEFORMS ARE FREEZING. 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 11896691 ↗
• MalfunctionMay 12, 2021Inadequate User Interface; Inadequate User Interface

  THE CUSTOMER REPORTED THAT DURING PATIENT SURGERY, ONLY THE SPEED OF THE ELECTRODE WAS CHANGED, AND THE PHYSICIAN HAD TO CORRECT IT MANUALLY. 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 11810833 ↗
• MalfunctionApr 22, 2021Device Sensing Problem

  THE CUSTOMER REPORTED THAT THE XIM: ECG WAVEFORM CLIPPING. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712169 ↗
• MalfunctionApr 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE HEMO DATA ON THE HOST IS NOT MATCHING WHAT IS ON THE BOOM. 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 11665394 ↗
• MalfunctionMar 30, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE EKG SWEEP FREEZES AND THE FLEX UNIT HAS TO BE REBOOTED TO CONTINUE CASE. 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 11592452 ↗
• MalfunctionDec 17, 2020Operating System Becomes Nonfunctional

  THE CUSTOMER REPORTED THAT THE HEMO PARAMETER WAS FROZEN ON THE FLEXVISION MONITOR.THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: Insufficient Information

  MAUDE report 11029794 ↗
• MalfunctionOct 29, 2020Display or Visual Feedback Problem

  THE CUSTOMER STATED THAT THE MONITOR INSIDE THE ROOM GETS FASTER, AND THE ELECTROCARDIOGRAM CANNOT BE SEEN. 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 10756030 ↗
• MalfunctionOct 13, 2020Delayed Program or Algorithm Execution

  ACCORDING TO THE CUSTOMER FEEDBACK, THE PROBLEM IN SCOPE WAS A DELAY OF ABOUT 10 SECONDS BETWEEN THE TRACE ON THE SCREEN AND THE ACTUAL RHYTHM OF THE PATIENT WAS OBSERVED, WHICH THE CUSTOMER BELIEVES IS ONE OF THE ELEMENTS THAT TRIGGERED THE PATIENTS DEATH.

  Patient problems: Death

  MAUDE report 10671425 ↗
• MalfunctionSep 29, 2020No Audible Prompt/Feedback

  THE CUSTOMER REPORTED NO SOUND COMING FROM THE DEVICE. 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 10600569 ↗
• MalfunctionJul 15, 2020Defective Component

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10276719 ↗
• InjuryJul 2, 2020Defective Device

  THE CUSTOMER REPORTED THAT, DURING A PROCEDURE, A DELAY OF APPROXIMATELY 10 SECONDS WAS NOTED BETWEEN THE PLOT AND THE ACTUAL DATA. THE PATIENT HAD A CARDIAC ARREST, THE DELAY OBSERVED OF WHICH IS APPARENTLY NOT THE CAUSE, BUT WHICH WAS DETECTED WITH THESE 10 SECONDS OF DELAY. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN SENT.

  Patient problems: Cardiac Arrest

  MAUDE report 10223289 ↗
• MalfunctionJun 30, 2020Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) READINGS KEEP REPEATING. THE DEVICE WAS NOT IN CLINICAL USE.

  Patient problems: No Patient Involvement

  MAUDE report 10214942 ↗
• MalfunctionJun 30, 2020Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE VIDEO LOCKS UP ON THE SECONDARY MONITORS. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10214053 ↗
• MalfunctionJun 22, 2020Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE ECG TRACES ON THE FLEXVISION AND SECONDARY MONITOR WERE FROZEN. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181106 ↗
• MalfunctionApr 15, 2020Output Problem

  THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) WAS NOT CHANGING READINGS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9962122 ↗
• MalfunctionApr 15, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING DUPLICATE NIBP (NON-INVASIVE BLOOD PRESSURE) VALUES. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962072 ↗