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Transmitters And Receivers, Physiological Signal, Radiofrequency

Open-data reference.

FDA MAUDE adverse event data · 1996–2026

What the Data Shows About Transmitters And Receivers, Physiological Signal, Radiofrequency

The FDA MAUDE database aggregates 1,684 adverse-event reports for Transmitters And Receivers, Physiological Signal, Radiofrequency spanning the period from 1996 through 2026. Of these, 73 are classified as death reports, 51 as injury reports, and 1,538 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 12 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 Communication or Transmission Problem topping the list at 316 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 484 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 8 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.

1,684
Total Reports
73
Death Reports
51
Injury Reports
1,538
Malfunctions

Event Types

Malfunction 1,538 (91.3%)
Death 73 (4.3%)
Injury 51 (3.0%)
11 (0.7%)
Other 11 (0.7%)

Patient Outcomes

1,518 (89.1%)
Death 74 (4.3%)
Other 50 (2.9%)
Required Intervention 22 (1.3%)
Hospitalization 9 (0.5%)
Life Threatening 8 (0.5%)
R 7 (0.4%)
L 5 (0.3%)
O 4 (0.2%)
S 3 (0.2%)
Disability 2 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Communication or Transmission Problem 316
Thermal Decomposition of Device 279
Failure to Power Up 174
Adverse Event Without Identified Device or Use Problem 94
Device Operates Differently Than Expected 81
Charred 58
Power Conditioning Problem 57
Output Problem 37
Overheating of Device 32
Intermittent Communication Failure 31
Device Inoperable 23
Computer Software Problem 20
Loss of Power 19
No Display/Image 15
Power Problem 15
Signal Artifact/Noise 15
Temperature Problem 15
Wireless Communication Problem 15
Break 14
Radio Signal Problem 14

Yearly Trend

96
1996: 10
97
1997: 11
98
1998: 9
99
1999: 2
00
2000: 9
01
2001: 20
02
2002: 11
03
2003: 11
04
2004: 31
05
2005: 12
06
2006: 10
07
2007: 14
08
2008: 9
09
2009: 5
10
2010: 13
11
2011: 12
12
2012: 9
13
2013: 13
14
2014: 97
15
2015: 131
16
2016: 182
17
2017: 484
18
2018: 166
19
2019: 70
20
2020: 82
21
2021: 107
22
2022: 43
23
2023: 19
24
2024: 26
25
2025: 53
26
2026: 13

Related Entities for Transmitters And Receivers, Physiological Signal, Radiofrequency

Event Locations

I 842 (50.0%)
HOSPITAL 419 (24.9%)
402 (23.9%)
INVALID DATA 8 (0.5%)
NO INFORMATION 6 (0.4%)
OTHER 4 (0.2%)
HOME 2 (0.1%)
UNKNOWN 1 (0.1%)

Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs NIHON KOHDEN CORPORATION →

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.