Infinity Mpod Quad Hemo MS20725Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098003667), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K113798); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED INACCURATE READINGS. THE ANESTHESIA ASSISTANT REPORTED THAT THE MPOD QUAD HEMO GAVE "INACCURATE" ARTERIAL VALUES AND REQUIRED RE-ZEROING TO GET ACCURATE VALUES. THE USERS RE-ZEROED THE QUA HEMO THREE TIMES, AND THEN REPLACED IT WITH ANOTHER DEVICE. ONCE THE USERS SWITCHED TO THE OTHER QUAD HEMO, THE HEMO GAVE THE EXPECTED PRESSURES. THE BIOMED AT THE CUSTOMER SITE HAD TESTED THE DEVICE ON AN EDWARDS IBP SIMULATOR WITH NO MALFUNCTION FOUND AND RETURNED IT TO SERVICE. THE MALFUNCTION OCCURRED AGAIN ON JUNE 30TH. THE CUSTOMER BIOMED TESTED AGAIN AND FOUND THAT THE PRESSURES WOULD NOT CHANGE FROM 0MMHG INTERMITTENTLY, WHEN IT WAS THEN REPORTED TO DRAEGER. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113798. One submission often covers many models, so check the product and lot details in each record.

• Z-1104-2021 · Dec 23, 2020 · Open, Classified
  Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in enviro
• Z-0258-2020 · Sep 13, 2019 · Open, Classified
  The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
• Z-1813-2018 · Mar 28, 2018 · Terminated
  Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 40490980544
• Z-1382-2018 · Feb 21, 2018 · Terminated
  Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Infor
• Z-0942-2018 · Oct 4, 2017 · Terminated
  INFINITY DUAL HEMO MCable Pod
• Z-2734-2017 · Jun 6, 2017 · Terminated
  Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
• Z-0714-2014 · Dec 10, 2013 · Terminated
  Draeger Infinity Acute Care System Monitoring Solution
• Z-0939-2013 · Dec 13, 2012 · Terminated
  Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.