Level 1 ER400-9Recalls & reported problems

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30695085000444), received between Aug 7, 2018 and Sep 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training 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.

Most reported problems

Device problems

Labelling, Instructions for Use or Training Problem1
Use of Device Problem1

Patient problems

Cardiopulmonary Arrest1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 6, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER CONFIRMED THE PRODUCT AND A DIFFERENT PRODUCT WERE IN THE SAME PACKAGE. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15364267 ↗
InjuryAug 7, 2018Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING DAILY CARE, THE VENTILATOR TUBING BECAME DISLODGED FROM THE ENDOTRACHEAL TUBE (ETT). BECAUSE THE CONNECTOR FOR THE ETT FIT WELL INTO THE SMITHS MEDICAL TEMPERATURE PROBE, THE VENTILATOR WAS INADVERTENTLY CONNECTED TO THE TEMPERATURE PROBE; THEREFORE, THE TEMPERATURE PROBE WAS VENTILATED. APPROXIMATELY 10 MINUTES LATER, THE PATIENT CODED, AND THIS ERROR WAS DISCOVERED. THE PATIENT WAS RESUSCITATED AND THE CONDITION RESOLVED.
Patient problems: Cardiopulmonary Arrest
MAUDE report 7759281 ↗

Device details

UDI-DI	`30695085000444`
Brand	Level 1
Model	ER400-9
Company	Icu Medical, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	K863646
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 16, 2025

Device type (GMDN): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.