Infinity M300+ MS33950Recalls & reported problems
Draeger Medical Systems, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098095730), received between Apr 8, 2025 and Apr 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Wireless Communication Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THE INFINITY CENTRAL STATION (ICS) ALERTED THAT THE M300+ TELEMETRY MONITOR WAS OFFLINE. THE ICS READ "DISCHARGE" WITHOUT THE PATIENT BEING DISCHARGED. AFTER A FEW MINUTES, THE ICS SHOWED THE M300+ ONLINE AND RECORDING WORKED IMMEDIATELY. ALTHOUGH THE ICS OPERATED AS INTENDED AND DISPLAYED AN "OFFLINE" MESSAGE ALERTING THE USER TO THE CONDITION, THE M300+ BESIDE MONITOR DISCHARGED THE PATIENT. REPORTING ON NEAR INCIDENT AS PATIENT DATA THAT IS LOST DUE AN UNINTENDED DISCHARGE COULD IMPACT PATIENT TREATMENT. IN THIS CASE, THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21799515 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.