INFINITY M300 Nellcor WPA2 MS26076Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049098002035), received between Jul 29, 2023 and Nov 10, 2025 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K130711); 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 16, 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.

• MalfunctionNov 10, 2025Telemetry Discrepancy; Communication or Transmission Problem; Telemetry Discrepancy; Communication or Transmission Problem

  IT WAS REPORTED THAT THE M300 TELEMETRY MONITOR WAS DISCHARGING ON ITS OWN WITHOUT ANY USER INTERACTION. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510112 ↗
• MalfunctionOct 31, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT AFTER THE CUSTOMER HOSPITAL UPDATED THEIR WIRELESS INFRASTRUCTURE, THEIR M300 DEVICES WOULD RANDOMLY LOSE CONNECTION TO THE INFINITY NETWORK, AND THE DEVICES WOULD GO OFFLINE FOR BRIEF MOMENTS OF TIME. THERE WAS ONE EVENT THAT OCCURRED ON (B)(6) 2024 WHILE AN M300 WAS IN USE WITH A PATIENT, AND IT DROPPED OFFLINE FROM 11:24 AM - 11:34 AM. THERE WAS NO ADVERSE PATIENT IMPACT AS RESULT OF THIS EVENT AND THE DEVICE APPROPRIATELY ALERTED THE USER OF THE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579956 ↗
• MalfunctionMay 20, 2024Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE M300 TRANSMISSION TO THE ICS WAS SPORADICALLY DISRUPTED. DETAILS REGARDING THE LENGTH AND FREQUENCY OF THE DISRUPTIONS WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355075 ↗
• DeathJul 29, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE DRAEGER INFINITY M300 FAILED TO ALARM DURING AN EVENT. THE PATIENT WAS RESUSCITATED BUT LATER DIED.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130711. One submission often covers many models, so check the product and lot details in each record.

• Z-1012-2022 · Mar 4, 2022 · Open, Classified
  Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
• Z-0372-2020 · Oct 9, 2019 · Open, Classified
  Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301