Xper Flex Cardio Physiomonitoring System FC 2020 (REF 453564243601)Recalls & reported problems
Philips Ds North America LLC · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838083516), received between May 31, 2019 and Mar 31, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (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
- 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
Device problems
- Device Alarm System3
- Incorrect, Inadequate or Imprecise Result or Readings2
- Operating System Becomes Nonfunctional1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
THE CUSTOMER REPORTED THAT THE VITALS WERE FREEZING DURING CASES. 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 11597388 ↗MalfunctionNov 29, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) WILL GIVE THE SAME READING UNTIL MANUALLY GETTING ONE. 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 10916214 ↗MalfunctionMar 20, 2020Device Alarm System
THE CUSTOMER REPORTED ALARM ISSUE ON ALL BEDSIDES. 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 9860647 ↗MalfunctionMar 19, 2020Device Alarm System
THE CUSTOMER REPORTED ALARM ISSUE ON ALL BEDSIDES. 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 9856239 ↗MalfunctionMar 19, 2020Device Alarm System
THE CUSTOMER REPORTED ALARM ISSUE ON ALL BED SIDES. 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 9856129 ↗MalfunctionMay 31, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED ONGOING NIBP (NON-INVASIVE BLOOD PRESSURE) ISSUES, WHERE THE DEVICE WOULD GIVE THE SAME READINGS AT LEAST TWO TIMES IN A ROW. THERE WAS NO REPORTED PATIENT IMPACT/INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8658584 ↗
Other MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) devices
- Rad-97 9738Masimo Corporation · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 death222 reports
- Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV CPhilips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls1 death42 reports
- Xper Flex Cardio Physiomonitoring System FC 2010Philips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 deaths38 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.