FDA Adverse Event Malfunction Summary report: N

ACUMEN IQ PLUS

MDR report key: 24942701 · Received April 21, 2026

Report

Report Number: 2015691-2026-14562
Event Type: Malfunction
Date Received: April 21, 2026
Date of Event: April 6, 2026
Report Date: April 21, 2026
Manufacturer: EDWARDS LIFESCIENCES DR
Product Code: DQK
UDI-DI: 00690103219531
PMA / PMN Number: K243781
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL PRODUCT CODES: DQE, QAQ, MUD, DXN, DSB, FLL, QMS, OLW. DEVICE WILL NOT BE RETURNED. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH THE PROVIDED CLINICAL PHOTOS, A CLINICAL EVALUATION WAS INITIATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem · 0

IT WAS REPORTED THAT, DURING USE, AN ACUMEN CUFF HAD INACCURATE VALUES COMPARED TO A SWAN GANZ CATHETER. THE PATIENT WAS ON EPI 0.07, LEVO 0.02 AND 0.25 MILRINONE. THE SWAN GANZ READINGS WERE IN LINE WITH THE PATIENT'S OVERALL PICTURE. LACTATE WAS DOWN TRENDING TO 2.7 AND THE SWAN STROKE VOLUME READING WAS 58 WHILE THE ACUMEN READING WAS 88. SQUARE WAVE TESTS WERE PERFORMED ON ALL PRESSURED LINES AND NO ERROR MESSAGES WERE DISPLAYED. AN ALTA MONITOR WAS USED IN THE CASE. NO ALLEGATION OF PATIENT INJURIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
553289	ACUMEN IQ PLUS	COMPUTER, DIAGNOSTIC, PROGRAMMABLE	DQK	EDWARDS LIFESCIENCES DR	AIQCA2		00690103219531

Patients

Seq	Age	Sex	Outcome	Treatment
1