Cardiovascular · 510(k) · 2019
Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure
Edwards Lifeciences, LLC. Cleared by FDA on 21 May 2019 under submission K183646, product code QAQ (adjunctive predictive cardiovascular indicator). What FDA's record says, in FDA's words.
Device record · K183646
- Device. Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - PressureDEVICE
- Company. Edwards Lifeciences, LLCCOMPANY
- Decision. 21 May 2019, 510(k), substantially equivalent (traditional review); received 26 December 2018DECISION
- Panel. CardiovascularPANEL
- Product code. QAQ, Adjunctive Predictive Cardiovascular IndicatorCODE
- Regulation. 21 CFR 870.2210, Class IIREG
- Source. FDA database entry · decision document (5 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non- surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
The product code's definition, from FDA's classification record. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 31 reports filed against devices carrying product code QAQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
14 January 2026 · Injury · HEMOSPHERE · EDWARDS LIFESCIENCES · report 2015691-2026-10408
AS REPORTED, DURING USE IN PATIENT, A HEMOSPHERE MONITOR WAS ON DEMO MODE FOR A NIGHT WITH A FLOTRAC SENSOR AND OXIMETRY CATHETER. ALTHOUGH "DEMO MODE" WAS DISPLAYED ON THE MONITOR, THE PHYSICIAN WHO PERFORMED CALIBRATION DID NOT REALIZE THAT IT WAS DEMO MODE. ON THE NEXT MORNING, THE NURSE NOTICED IT WAS DEMO MODE AS THE WAVEFORM DID NOT BECOME FLAT BY OPENING THE VENT PORT TO THE ATMOSPHERE WHEN ATTEMPTED TO ZERO THE FLOTRAC SENSOR. THE BLOOD PRESSURE WAVEFORM HAD BEEN MONITORED CORRECTLY […]
18 November 2025 · Malfunction · HEMOSPHERE ALTA · EDWARDS LIFESCIENCES · report 2015691-2025-09384
IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WAS SIGNIFICANTLY INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THE FOLLOWING […]
18 November 2025 · Malfunction · HEMOSPHERE ALTA · EDWARDS LIFESCIENCES · report 2015691-2025-09385
IT WAS REPORTED THAT, DURING USE, THE CARDIAC OUTPUT AND CARDIAC INDEX WAS INCORRECT ON THE HEMOPSHERE ALTA ALL 1 MONITOR. THE CABLE WAS CHANGED OUT BUT THE ISSUE CONTINUED. THE PHYSICIAN LOST CONFIDENCE IN THIS PARTICULAR MONITOR. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED ISSUE.
18 November 2025 · Malfunction · HEMOSPHERE ALTA · EDWARDS LIFESCIENCES · report 2015691-2025-09382
IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WERE INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY HAS OCCURRED REPEATEDLY SEVERAL TIMES PER DAY ACROSS MULTIPLE CASES AND APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS […]
25 September 2025 · Malfunction · HEMOSPHERE · EDWARDS LIFESCIENCES · report 2015691-2025-07892
AS REPORTED, DURING USE IN PATIENT, A HEMOSPHERE MONITOR DISPLAYED INACCURATE CENTRAL VENOUS PRESSURE (CVP) VALUES WHILE CONNECTED TO A NIHON-KODEN PATIENT MONITOR VIA AN ANALOG PORT. WHEN VOLTAGE RANGE WAS SET TO 0-1 VOLTS, CVP WAS DISPLAYED AS OUT OF RANGE (-). WHEN VOLTAGE RANGE WAS CHANGED TO 0-5 OR 0-10 VOLTS, CVP WAS DISPLAYED AS 0 MMHG. CVP WAS ALSO SHOWN AS 0 MMHG WHEN THE ANALOG CABLE WAS CONNECTED TO ONLY THE HEMOSPHERE MONITOR WITHOUT CONNECTING TO THE PATIENT MONITOR. THE EXPECTED […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAQ, in Cardiovascular, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.