Philips Hemodynamic Application Philips Hemodynamic Application - 1Recalls & reported problems
Philips Medical Systems Nederland B.V. · Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838084544), received between Jun 15, 2020 and Nov 6, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 FDA recall record name this device's identifier.
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
- Feb 22, 2022Terminated
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Z-1041-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- No Display/Image1
- Unable to Obtain Readings1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
IT HAS BEEN REPORTED TO PHILIPS THAT DURING A RIGHT HEART CATHERIZATION PROCEDURE THERE WERE ISSUES WITH THE PHILIPS HEMODYNAMIC SYSTEM. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS MOVED TO ANOTHER CATH LAB WHERE THE PROCEDURE NEEDED TO BE REPEATED. THIS RESULTED IN PROLONGED HOSPITALIZATION FOR THE PATIENT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 10799209 ↗MalfunctionOct 30, 2020No Display/Image; No Display/Image
PHILIPS HAS INVESTIGATED THIS COMPLAINT AND CONCLUDED THAT THERE WAS NO MALFUNCTION OF THE HEMODYNAMIC APPLICATION. THE PHILIPS HEMODYNAMIC APPLICATION WORKS TOGETHER WITH A MONITORING DEVICE (PHILIPS XPER FLEXCARDIO). ANALYSIS OF THE LOG FILES OF THE MONITORING DEVICE CONFIRMED THAT THE ECG LEADS CONNECTED TO THE PATIENT WERE LOOSE. BASED ON THE INVESTIGATION RESULTS, PHILIPS HAS CONCLUDED THAT THERE WAS NO MALFUNCTION. THE REPORTED ISSUE IS NOT CONSIDERED A REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10761464 ↗MalfunctionJun 15, 2020Unable to Obtain Readings
IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOGRAPHY (CAG), VISUALS OF ALL HEMODYNAMICS APPLICATION READINGS WERE LOST FOR A WHILE DURING THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10153445 ↗
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.