Infinity Kappa Monitor MS18853Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049098004039), received between Jul 27, 2023 and Jun 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K070566); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE INFINITY KAPPA MONITOR WAS USED BY THE ANESTHESIOLOGIST TO MONITOR THE VITAL SIGNS OF A PATIENT WHO WAS UNDER GENERAL ANESTHESIA. AFTER THE ENDOTRACHEAL INTUBATION AND SURGICAL DRAPING WAS PERFORMED, THE MONITOR SCREEN SUDDENLY BLACKED OUT AND THE ANESTHESIOLOGIST COULD NO LONGER ADJUST THE ANESTHESIA DEPTH BASED ON THE PATIENT'S VITAL SIGNS. THEY RELIED ON PALPITATION OF THE CAROTID PULSE AND CARDIAC AUSCULTATION TO MONITOR THE PATIENT'S CONDITION; HOWEVER, DUE TO CONCERNS ABOUT UNDETECTED CHANGES IN THE PATIENT'S STATUS, THE SURGEON DID NOT WANT TO PROCEED WITH THE OPERATION WITHOUT A FUNCTIONAL MONITOR. THE KAPPA WAS RESTARTED, AND THE CABLES WERE RECONNECTED TO TROUBLESHOOT THE ISSUE; HOWEVER, THE ISSUE PERSISTED. THE EFFECTED MONITOR WAS REPLACED WITH A BACKUP MONITOR TO CONTINUE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359435 ↗
• MalfunctionMay 28, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE KAPPA SCREEN "GREYED OUT" DURING SURGERY, AND THAT THE AUDIBLE PROMPTS AND ALARMS WERE STUFF PRESENT. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: Insufficient Information

  MAUDE report 19404029 ↗
• MalfunctionFeb 14, 2024Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THE PATIENT REQUIRED THE USE OF THE CARDIAC MONITOR TO MONITOR THE VITAL SIGNS DURING SURGERY. IT WAS NOTED THAT THERE WAS NO ABNORMALITY OBSERVED DURING THE USE, BUT THE OPERATOR FOUND THAT THE ECG LEADS COULD NOT BE DISPLAYED NORMALLY AS THERE WAS INTERFERENCE. THE USE OF THE KAPPA MONITOR WAS IMMEDIATELY STOPPED AND REPLACED BY ANOTHER ONE. THERE IS NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702385 ↗
• InjuryJul 27, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT WHEN THE ANESTHESIOLOGY DEPARTMENT USED THE MONITOR TO MONITOR THE VITAL SIGNS OF PATIENTS UNDERGOING OPHTHALMIC SURGERY, THE SCREEN SUDDENLY WENT BLACK. AFTER THE EQUIPMENT MAINTENANCE ENGINEER ARRIVED, HE USED AN EXTERNAL DISPLAY SCREEN FOR THE OPERATION TO CONTINUE. THOUGH NO ADVERSE PATIENT IMPACT WAS REPORTED, A DELAY IN TREATMENT CANNOT BE EXCLUDED FOR HAVING OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409874 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070566. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2012 · Oct 31, 2011 · Terminated
  Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
• Z-3048-2011 · Jul 29, 2011 · Terminated
  Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside a
• Z-3047-2011 · Jul 29, 2011 · Terminated
  Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and tr
• Z-2283-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-2284-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-0582-2010 · Nov 9, 2009 · Terminated
  Delta/Delta XL Monitors with Omega S Package