2026 data FDA MAUDE openFDA FDA Class II

Cable, Transducer And Electrode, Patient, (Including Connector)

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 §870.2900 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Cable, Transducer And Electrode, Patient, LIGHT-BOOK · MAUDE

#815 of 1000 · 622 reports · 1992–2026

  • BOOK 622 reports
  • RANK #815 of 1000
  • DEATH 17 death-typed
  • INJ 95 injury-typed
  • MALF 493 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 77
  • PHOTO Gram-Positive Bacteri…

Nearest event-volume peer: Gram-Positive Bacteria And Their Resistance Markers (1 report gap)

Cable, Transducer And Electrode, Patient, (Including Connector) sits #815 of 1000 among tracked device types with 622 MAUDE reports spanning 1992–2026. 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

Cable, Transducer And Electrode, Patient, carries 15.3% INJURY-coded reports, 15.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.7% corpus 1.5% · above corpus mean (+1.2 pp)
  • INJ 15.3% corpus 30.3% · below corpus mean (-15.0 pp)
  • MALF 79.3% corpus 64.8% · above corpus mean (+14.4 pp)

Lead product-problem code Material Integrity Problem is 35% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 59% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Cable, Transducer And Electrode, Patient, in the event-volume neighbourhood

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

reports

What this shows Cable, Transducer And Electrode, Patient, (Including Connector) carries 622 MAUDE reports, ranked #815 of 1000.

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

Event Types

Malfunction 493 (79.3%)
Injury 95 (15.3%)
Death 17 (2.7%)
Other 9 (1.4%)
8 (1.3%)

Patient Outcomes

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

444 (67.7%)
Other 71 (10.8%)
Required Intervention 49 (7.5%)
Life Threatening 33 (5.0%)
R 26 (4.0%)
Death 16 (2.4%)
Hospitalization 8 (1.2%)
L 7 (1.1%)
O 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Material Integrity Problem 181
Device Operates Differently Than Expected 70
Failure to Capture 32
Connection Problem 24
Blocked Connection 21
Incorrect, Inadequate or Imprecise Result or Readings 18
Loose or Intermittent Connection 17
Defective Component 15
Device Inoperable 15
Cable, defective 14
Device Displays Incorrect Message 14
Adverse Event Without Identified Device or Use Problem 12
Defective Device 12
Replace 12
Break 11
Device Sensing Problem 11
Display or Visual Feedback Problem 11
No Device Output 11
Output Problem 11
Communication or Transmission Problem 10

Yearly Trend

92
1992: 6
93
1993: 1
94
1994: 4
95
1995: 2
96
1996: 3
97
1997: 10
98
1998: 19
99
1999: 21
00
2000: 10
01
2001: 3
02
2002: 6
03
2003: 4
04
2004: 7
05
2005: 5
06
2006: 3
07
2007: 4
08
2008: 11
09
2009: 5
10
2010: 1
11
2011: 4
12
2012: 8
13
2013: 23
14
2014: 67
15
2015: 34
16
2016: 28
17
2017: 5
18
2018: 16
19
2019: 11
20
2020: 31
21
2021: 7
22
2022: 49
23
2023: 29
24
2024: 40
25
2025: 68
26
2026: 77

Reports rose to 68 in 2025, up from an average of 35 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Cable, Transducer And Electrode, Patient, (Including Connector)

Event Locations

395 (63.5%)
I 102 (16.4%)
HOSPITAL 99 (15.9%)
NO INFORMATION 9 (1.4%)
OTHER 6 (1.0%)
UNKNOWN 5 (0.8%)
INVALID DATA 4 (0.6%)
HOME 2 (0.3%)

Compare MEDTRONIC, INC. vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

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

Disclaimer: MAUDE figures for Cable, Transducer And Electrode, Patient, 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 Cable, Transducer And Electrode, Patient,; 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.