2026 data Public-data reference. official source

Condenser, Heat And Moisture (Artificial Nose)

Open-data reference.

FDA MAUDE adverse event data · 1996–2026

What the Data Shows About Condenser, Heat And Moisture (Artificial Nose)

The FDA MAUDE database aggregates 411 adverse-event reports for Condenser, Heat And Moisture (Artificial Nose) spanning the period from 1996 through 2026. Of these, 11 are classified as death reports, 59 as injury reports, and 319 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 5 distinct event types and 9 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 Disconnection topping the list at 38 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 31 years of MAUDE data, with the peak single-year volume reaching 52 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 9 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.

411
Total Reports
11
Death Reports
59
Injury Reports
319
Malfunctions

Event Types

Malfunction 319 (77.6%)
Injury 59 (14.4%)
Other 15 (3.6%)
Death 11 (2.7%)
7 (1.7%)

Patient Outcomes

318 (75.4%)
Required Intervention 49 (11.6%)
Other 16 (3.8%)
Life Threatening 14 (3.3%)
R 10 (2.4%)
Death 10 (2.4%)
Hospitalization 3 (0.7%)
L 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Disconnection 38
Leak/Splash 33
Material Separation 25
Material Split, Cut or Torn 15
Obstruction of Flow 15
Crack 14
Defective Device 14
Moisture or Humidity Problem 14
Gas/Air Leak 13
Break 10
Loose or Intermittent Connection 9
Fitting Problem 7
Fracture 7
Gradient Increase 5
Appropriate Term/Code Not Available 4
Contamination /Decontamination Problem 4
Difficult or Delayed Activation 4
Filtration Problem 4
Insufficient Information 4
Detachment of Device or Device Component 3

Yearly Trend

96
1996: 4
97
1997: 11
98
1998: 12
99
1999: 9
00
2000: 11
01
2001: 7
02
2002: 5
03
2003: 3
04
2004: 3
05
2005: 10
06
2006: 8
07
2007: 4
08
2008: 2
09
2009: 2
10
2010: 9
11
2011: 7
12
2012: 4
13
2013: 4
14
2014: 6
15
2015: 17
16
2016: 18
17
2017: 12
18
2018: 33
19
2019: 15
20
2020: 35
21
2021: 15
22
2022: 32
23
2023: 45
24
2024: 10
25
2025: 52
26
2026: 6

Related Entities for Condenser, Heat And Moisture (Artificial Nose)

Event Locations

182 (44.3%)
I 137 (33.3%)
HOSPITAL 76 (18.5%)
INVALID DATA 5 (1.2%)
UNKNOWN 4 (1.0%)
HOME 3 (0.7%)
NO INFORMATION 2 (0.5%)
NURSING HOME 1 (0.2%)
OTHER 1 (0.2%)

Compare TELEFLEX MEDICAL SDN. BHD. vs TELEFLEX MEDICAL →

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.