Tempus Pro 01-2052Recalls & reported problems
Remote Diagnostic Technologies Limited · Invasive Pressure Cable 2 Channel - Edwards TruWave 8 ft · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060472440143), received between Dec 21, 2025 and Dec 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
THIS REPORT IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO, INDICATING DISCREPANCY BETWEEN THE LEGAL MANUFACTURER¿S ADDRESS ON THE PRODUCT LABEL AND THE EUDAMED DATABASE, INCLUDING MISSING COUNTRY-SPECIFIC INFORMATION (¿EX NORTHERN IRELAND¿).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23860553 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.