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Continuous Measurement Thermometer

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Continuous Measurement Thermometer

The FDA MAUDE database aggregates 1,271 adverse-event reports for Continuous Measurement Thermometer spanning the period from 1992 through 2026. Of these, 13 are classified as death reports, 171 as injury reports, and 935 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 6 distinct event types and 14 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Excessive Heating topping the list at 317 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 142 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 12 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

1,271
Total Reports
13
Death Reports
171
Injury Reports
935
Malfunctions

Event Types

Malfunction 935 (73.6%)
Injury 171 (13.5%)
Other 114 (9.0%)
37 (2.9%)
Death 13 (1.0%)
No answer provided 1 (0.1%)

Patient Outcomes

698 (46.2%)
Other 377 (25.0%)
R 161 (10.7%)
Hospitalization 85 (5.6%)
Required Intervention 78 (5.2%)
O 68 (4.5%)
Death 13 (0.9%)
Life Threatening 11 (0.7%)
H 9 (0.6%)
Disability 4 (0.3%)
S 3 (0.2%)
L 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Invalid Data 1 (0.1%)

Top Product Problems

Excessive Heating 317
False Negative Result 151
Adverse Event Without Identified Device or Use Problem 86
Insufficient Information 68
Incorrect, Inadequate or Imprecise Result or Readings 51
Power Problem 33
Battery Problem 29
Low Readings 28
Product Quality Problem 28
Nonstandard Device 27
Use of Device Problem 24
Device Issue 22
Device Operates Differently Than Expected 18
Incorrect Interpretation of Signal 17
Invalid Sensing 16
Improper or Incorrect Procedure or Method 15
Incorrect Measurement 15
High Readings 13
Low Test Results 10
Patient Device Interaction Problem 10

Yearly Trend

92
1992: 5
93
1993: 2
94
1994: 5
95
1995: 7
96
1996: 10
97
1997: 30
98
1998: 29
99
1999: 16
00
2000: 9
01
2001: 9
02
2002: 14
03
2003: 5
04
2004: 4
05
2005: 6
06
2006: 20
07
2007: 4
08
2008: 13
09
2009: 9
10
2010: 9
11
2011: 18
12
2012: 26
13
2013: 16
14
2014: 54
15
2015: 53
16
2016: 58
17
2017: 118
18
2018: 51
19
2019: 52
20
2020: 53
21
2021: 115
22
2022: 142
23
2023: 101
24
2024: 118
25
2025: 76
26
2026: 14

Related Entities for Continuous Measurement Thermometer

Event Locations

659 (51.8%)
I 293 (23.1%)
HOSPITAL 168 (13.2%)
NO INFORMATION 59 (4.6%)
HOME 53 (4.2%)
INVALID DATA 12 (0.9%)
UNKNOWN 11 (0.9%)
OTHER 8 (0.6%)
OUTPATIENT TREATMENT FACILITY 3 (0.2%)
NURSING HOME 2 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)
NOT APPLICABLE 1 (0.1%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.