Xper Flex Cardio Physiomonitoring System FC2010 (REF 453564241901)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884838103610), received between Feb 9, 2021 and Jul 5, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A DEFIB-IMPLANTATION PROCEDURE, THE ECG CURVES FLAT LINED AND THERE WAS NO SPO2 DISPLAYED. PATIENT OUTCOME IS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14917225 ↗
• MalfunctionMar 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SOMETIMES THE SWEEP SPEED CHANGES AUTOMATICALLY. 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 13770651 ↗
• MalfunctionJan 28, 2022Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE NON-INVASIVE BLOOD PRESSURE READINGS ARE DUPLICATING AND NOT TAKING NEW BLOOD PRESSURES EVERY FIVE MINUTES AS IT IS SET TO. 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 13385456 ↗
• MalfunctionJun 7, 2021Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE DEVICE ONLY SHOWS DUPLICATED NIBP (NON-INVASIVE BLOOD PRESSURE) MEASUREMENTS FOR EVERY 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 11952530 ↗
• MalfunctionMay 21, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED SPO2 SPECIFICATIONS IN THE EXAMINATION ROOM WITHOUT SOUND. NO VITAL SIGNS SOUND FOR SPO2 MAKES IT DIFFICULT TO CONTINUE WORKING. 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 11866515 ↗
• MalfunctionMay 6, 2021Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE SWEEP SPEED CHANGING AUTOMATICALLY DURING PROCEDURE. 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 11782593 ↗
• MalfunctionMay 4, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED AN ECG HANG ISSUE. THE DISPLAY IS 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 11769966 ↗
• MalfunctionApr 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REQUESTED TO HAVE THE DEVICE SWAPPED OUT DUE TO THE QRS COMPLEX BEING ¿CLIPPED¿ AT 187MMHG WHEN DOING FFR (FRACTIONAL FLOW RESERVE). 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 11667474 ↗
• MalfunctionApr 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REQUESTED TO HAVE THE DEVICE UPGRADED DUE TO THE QRS COMPLEX BEING ¿CLIPPED¿ AT 187MMHG WHEN DOING FFR (FRACTIONAL FLOW RESERVE). 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 11667280 ↗
• MalfunctionMar 4, 2021Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED OF THE PROGRAM HAS BEEN CHANGING AUTOMATICALLY AND IT APPEARS THAT THE PATIENTS HR IS NOT BEING DISPLAYED PROPERLY. IT HAPPENED TWICE THIS MORNING. THE SYSTEM HAS TWO SCREENS ONE IN THEATRE AND ONE ON THE VIEWING ROOM. THE SCREEN IN THE VIEWING ROOM IS THE ONE WHICH HAS THE CHANGE IN THE SWEEP SPEED. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11417816 ↗
• MalfunctionFeb 9, 2021Device Displays Incorrect Message

  THE CUSTOMER REPORTED THAT THE HEART RATE VALUE WAS STUCK AT 99 AND NOT UPDATING. 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 11301616 ↗