Kangaroo 386100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521164987), received between Apr 23, 2021 and Apr 7, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED DURING A PLACEMENT, THE IRIS CONSOLE WENT BLACK AND DID NOT TURN BACK ON AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700625 ↗
• MalfunctionFeb 7, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SCREEN IS BLACK/PIXELATED AND WILL NOT TURN ON. WHEN IT IS POWERED OFF THE SCREEN FLASHES WHITE AND GOES COMPLETELY DARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315135 ↗
• MalfunctionFeb 2, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE NEW CONSOLE WAS UNBOXED AND PLUGGED IN. ONCE THEY TRIED TO START THE CONSOLE, THE "COVIDIEN" SCREEN APPEARED BUT THEN IT WENT BLANK AND NEVER FULLY TURNED ON. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO PATIENT HARM/INVOLVEMENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283896 ↗
• MalfunctionAug 31, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE CONSOLE SCREEN CONTINUES TO FREEZE DURING IRIS PLACEMENTS. ADDITIONAL INFORMATION RECEIVED STATING THAT DEVICE SCREEN FREEZES AND WENT BLANK MULTIPLE TIMES.

  Patient problems: Insufficient Information

  MAUDE report 12396166 ↗
• MalfunctionMay 10, 2021No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE DEVICE STOPPED WORKING AND THE SCREEN TURNED OFF DURING PLACEMENT. THE CLINICIAN CHECKED AND REPLACED THE POWER ADAPTER CONNECTIONS AND THE INTERFACE CABLES, BUT THE SCREEN WOULD NOT TURN ON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SCREEN DID NOT FREEZE, THE SCREEN WENT BLACK AND THEY COULD NOT GET IT TO LIGHT BACK UP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802611 ↗
• MalfunctionApr 23, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED THAT BEFORE PLACEMENT, THEY WERE LOGGING INTO THE IRIS CONSOLE. THE DEVICE WOULD ALLOW THEM TO ENTER THE LOGIN INFORMATION AND GET TO THE SCREEN WITH THE FOUR ICONS BUT, WHEN THEY PRESS THE PATIENT ICON, THE SCREEN GLITCH THEN SHUT DOWN COMPLETELY. THE ISSUE OCCURRED TWICE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCREEN FROZE FOR A MOMENT AND WENT BACK TO NORMAL THEN TURNED OFF. THERE WAS A SLIGHT DELAY IN GETTING THE TUBE PLACED ALTHOUGH, NO PATIENT WAS INVOLVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712924 ↗