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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Transmitters And Receivers LIGHT-BOOK · MAUDE

#522 of 1000 · 1,684 reports · 1996–2026

  • BOOK 1,684 reports
  • RANK #522 of 1000
  • DEATH 73 death-typed
  • INJ 51 injury-typed
  • MALF 1,538 malfunction
  • SPAN 1996–2026
  • PEAK 2017: 484
  • PHOTO Covid-19 Multi-Analyt…

Nearest event-volume peer: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices (8 report gap)

Transmitters And Receivers, Physiological Signal, Radiofrequency sits #522 of 1000 among tracked device types with 1,684 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
  • INJ 3.0% corpus 30.4% · below corpus mean (-27.4 pp)
  • MALF 91.3% corpus 64.5% · above corpus mean (+26.8 pp)

Lead product-problem code Communication or Transmission Problem is 24% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 37% of manufacturer-tagged reports · Top event location I is 50% 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 1,684 MAUDE reports, ranked #522 of 1000.

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

Event Types

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

Patient Outcomes

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

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

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 477
NIHON KOHDEN CORPORATION 451
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 (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 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Transmitters And Receivers, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,684 here).

Covid-19 Multi-Analyte Respiratory Panel Nu… 1,692 Needle, Aspiration And Injection, Disposable 1,692 Ear, Nose, And Throat Stereotaxic Instrument 1,672 Marker, Radiographic, Implantable 1,671

Similar death-typed counts

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

Unit, Electrosurgical, Endoscopic 73 Catheter, Hemodialysis, Non-Implanted 72 Catheter, Ultrasound, Intravascular 72 Intestinal Stimulator 72

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.