INFINITY M500 WITH POWER MS20407Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049098054447), received between Jun 28, 2024 and Sep 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

3 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 13, 2024Open, Classified

   Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.

   Z-2189-2024 · Root cause: Device Design · FDA record ↗

2. Mar 28, 2018Terminated

   Software anomaly resulting in the loss of patient settings and stored patient data.

   Z-1813-2018 · Root cause: Under Investigation by firm · FDA record ↗

3. Feb 21, 2018Terminated

   The invasive pressure visual and audible alarms may not activate.

   Z-1382-2018 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Electrical Shorting; Insufficient Device Problem Information; Electrical Shorting; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE KEYBOARD CONNECTION CABLE WAS "SCORCHED" NEAR WHERE THE CABLE MEETS THE KEYBOARD. THE PICTURES PROVIDED CONFIRMED THE DAMAGE TO THE KEYBOARD CABLE. IT WAS REPORTED THAT NO ENTRY COULD BE MADE ON THE KEYBOARD RIGHT BEFORE THE DAMAGE TO THE CABLE WAS NOTICED. IT WAS ALSO CONFIRMED THERE WAS NO INJURY TO THE USER OR A PATIENT AND NO IMPACT ON ANY OTHER FUNCTION OF ICS MONITORING. THERE WAS NO ADVERSE PATIENT OR USER IMPACT OR DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225077 ↗
• MalfunctionJun 28, 2024Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WERE SEVERAL ALARMS BUT NO EVENTS SAVED. ALL CURVES ON THE ENTIRE CENTRAL MONITORING UNIT ARE CLOSED. CANNOT MAKE SETTINGS OR CLOSE ALARMS (FOR EXAMPLE). THE CENTRAL MONITORING UNIT STILL HAS A CURRENT DISPLAY OF PARAMETERS AND WAS REBOOTED AND CURRENTLY WORKS. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632840 ↗