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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838093645), received between Jun 21, 2021 and Sep 23, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 29, 2021Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868930 ↗
• InjuryJun 17, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE DEVICE TIMED OUT AND THE PATIENT WENT INTO RESPIRATORY ARREST DURING A RESTART. THE CUSTOMER INDICATED THE CUSTOMER NOTICED THE ARREST WHEN THE PATIENT BECAME UNRESPONSIVE. ADDITIONAL INFORMATION WAS NOT PROVIDED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Respiratory Arrest

  MAUDE report 25530744 ↗
• MalfunctionApr 15, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, DEFIBRILLATION OF THE PATIENT WAS REQUIRED, WHICH CAUSED SIGNALS TO BE LOST FOR MORE THAN THREE (3) MINUTES. ACCORDING TO THE CUSTOMER, THE DEVICE WAS REBOOTED AND THE PROCEDURE WAS COMPLETED NORMALLY WITHOUT PATIENT INCIDENT. THERE WAS NO ADVERSE IMPACT TO THE PATIENT OR THE PATIENT'S TREATMENT REPORTED BY THE CUSTOMER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117277 ↗
• MalfunctionMar 23, 2022Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch; Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING AN EMERGENCY PROCEDURE THE PATIENT REQUIRED DEFIBRILLATION. THE DOCTOR SHOCKED THE PATIENT ABOUT 11 TIMES. THE SYSTEM ASKED 2 TIMES TO RESTART. THE CUSTOMER HAD TO RESTART TO CONTINUE THE PROCEDURE SO HE COULD CONTINUE. THE DEVICE WAS IN USE AT TIME OF EVENT, IT IS UNKNOWN IF THERE WAS ANY ADVERSE EVENT TO PATIENT AT TIME OF EVENT. ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861207 ↗
• MalfunctionJun 21, 2021Power Problem; Power Problem

  IT WAS REPORTED TO PHILIPS THAT, DURING A PREVENTIVE MAINTENANCE FOR THE PHILIPS HEMO SYSTEM, THE ONSITE FIELD SERVICE ENGINEER (FSE) WENT TO DISCONNECT THE 230 VOLTS POWER PLUG FROM THE AC/DC ADAPTER (POWER SUPPLY FRONT END BOX) AND IN THAT MOMENT OF DISCONNECTING THERE WAS A SHORT FLAME OBSERVED. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037555 ↗