INFINITY M300 MS18501Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049098004183), received between Apr 3, 2024 and Nov 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1
No Audible Prompt/Feedback1
No Device Output1
Wireless Communication Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Insufficient Information1

Recent adverse event reports

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

MalfunctionNov 1, 2024Insufficient Device Problem Information; Wireless Communication Problem; Insufficient Device Problem Information; Wireless Communication Problem
IT WAS REPORTED THAT THE M300+ LOST CONNECTION TO THE WIRELESS NETWORK WHILE THE DEVICE WAS IN USE WITH A PATIENT. THERE WAS NO ADVERSE PATIENT IMPACT AND NO REPORT OF INJURY AT THE TIME OF THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20591824 ↗
MalfunctionApr 3, 2024No Device Output; No Audible Prompt/Feedback; No Device Output; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE WAS NO ALARM AT THE ICS WHEN AN ECG OR SPO2 CABLE IS DISCONNECTED FROM THE M300. THE USER AT THE CENTRAL WILL POTENTIALLY WILL NOT KNOW THAT THE PATIENT IS NO LONGER BEING MONITORED WHICH HAS THE POTENTIAL FOR ADVERSE PATIENT IMPACT. NO INJURY OR OTHER PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19037547 ↗

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

Device details

UDI-DI	`04049098004183`
Brand	INFINITY M300
Model	MS18501
Company	Draeger Medical Systems, Inc.
Product code	MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Class	Class 2
FDA submission	K130711
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Nov 10, 2021

Device type (GMDN): General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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All Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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