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2026 data FDA MAUDE openFDA FDA Class II

Transmitters And Receivers, Physiological Signal, Radiofrequency

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.2910 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Transmitters And Receivers LIGHT-BOOK · MAUDE

#533 of 1000 · 1,714 reports · 1996–2026

  • BOOK 1,714 reports
  • RANK #533 of 1000
  • DEATH 73 death-typed
  • INJ 52 injury-typed
  • MALF 1,567 malfunction
  • SPAN 1996–2026
  • PEAK 2017: 484
  • PHOTO Ear

Nearest event-volume peer: Ear, Nose, And Throat Stereotaxic Instrument (2 report gap)

Transmitters And Receivers, Physiological Signal, Radiofrequency sits #533 of 1000 among tracked device types with 1,714 MAUDE reports spanning 1996–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Transmitters And Receivers carries 3.0% INJURY-coded reports, 27.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
  • INJ 3.0% corpus 30.3% · below corpus mean (-27.3 pp)
  • MALF 91.4% corpus 64.8% · above corpus mean (+26.6 pp)

Lead product-problem code Communication or Transmission Problem is 21% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 36% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Transmitters And Receivers in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Transmitters And Receivers, Physiological Signal, Radiofrequency carries 1,714 MAUDE reports, ranked #533 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,567 (91.4%)
Death 73 (4.3%)
Injury 52 (3.0%)
11 (0.6%)
Other 11 (0.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,549 (89.3%)
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 360
Thermal Decomposition of Device 337
Failure to Power Up 177
Device Operates Differently Than Expected 135
Adverse Event Without Identified Device or Use Problem 101
Power Conditioning Problem 85
Charred 82
Device Alarm System 64
Overheating of Device 58
Device Inoperable 57
Output Problem 41
Intermittent Communication Failure 35
No Display/Image 33
Computer Software Problem 31
Melted 26
Loss of Power 23
Device Displays Incorrect Message 22
Temperature Problem 22
Wireless Communication Problem 21
Power Problem 19

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: 43

Reports rose to 53 in 2025, up from an average of 23 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Transmitters And Receivers, Physiological Signal, Radiofrequency

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 477
NIHON KOHDEN CORPORATION 475
ST. JUDE MEDICAL, INC. 152
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 83
ST. JUDE MEDICAL, INC., CRMD 69
PHILIPS MEDICAL SYSTEMS 36
COVIDIEN MFG DC BOULDER 19

Event Locations

I 842 (49.1%)
432 (25.2%)
HOSPITAL 419 (24.4%)
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 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Transmitters And Receivers: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,714 here).

Ear, Nose, And Throat Stereotaxic Instrument 1,712 Sleeve, Limb, Compressible 1,705 Apparatus 1,734 Covid-19 Multi-Analyte Respiratory Panel Nu… 1,693

Similar death-typed counts

Nearest other device types by death-typed report count (73 here), distinct from the volume row.

Catheter, Hemodialysis, Non-Implanted 73 Iliac Covered Stent, Arterial 73 Plate, Fixation, Bone 73 Intestinal Stimulator 74

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Transmitters And Receivers are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Transmitters And Receivers; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.