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Hypotension Decision Assist (HDA)

DIRECTED SYSTEMS LIMITED · Model HDA-OR1 · UDI-DI 00860003496701

DXG Prescription

510(k) clearances

774

Adverse events (16 deaths)

Recalls

Facilities

Description

Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.

Recalls

Date	Firm	Reason
2020-11-19	Lidco Ltd	The expiration date on labeling is incorrect.
2020-11-09	ICU Medical, Inc.	Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
2020-02-14	ICU Medical, Inc.	Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
2019-06-05	GETINGE US SALES LLC	The monitor displays an error message . The error message states "internal error restart or service".
2013-03-28	Transonic Systems Inc	Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
2010-06-25	Edwards Lifesciences, Llc	The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
2008-09-12	Edwards Lifesciences, Llc	Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00
2007-05-17	Edwards Lifesciences, Llc	MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of syst

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.