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Xper Flex Cardio Physiomonitoring System FC 2010 (REF 453564483331)Recalls & reported problems

Philips Ds North America LLC · Xper Flex Cardio Physiomonitoring System · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838083530), received between Jul 10, 2019 and Aug 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  1. 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

Device problems

  • Insufficient Device Problem Information1
  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 9, 2021Unable to Obtain Readings; Unable to Obtain Readings

    THE CUSTOMER REPORTED THAT DURING USE, THE SYSTEM WILL PAUSE, AND THE DISPLAY WILL FREEZE MOMENTARILY, THEN WILL RUN FAST TO CATCH UP TO REAL TIME, MAKING THE WAVEFORM LOOK LIKE ASYSTOLE (FLATLINE). ACCORDING TO THE CUSTOMER, EACH TIME THAT IT HAPPENED, THEY WOULD REBOOT THE DEVICE AND THE WORKSTATION IN ORDER TO GET THE FLEX 2020 TO FUNCTION CORRECTLY. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12296104 ↗
  • MalfunctionJul 10, 2019Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT ROOM 3 (IP (B)(4)) WAS POSTING THE SAME NIBP (NON-INVASIVE BLOOD PRESSURE) ON THE SEDATION FLOW SHEET. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8776306 ↗

Other MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) devices

All MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.