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2026 data FDA MAUDE openFDA FDA Class II

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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 §870.2300 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Monitor, Cardiac LIGHT-BOOK · MAUDE

#398 of 1000 · 3,110 reports · 1992–2026

  • BOOK 3,110 reports
  • RANK #398 of 1000
  • DEATH 575 death-typed
  • INJ 177 injury-typed
  • MALF 2,225 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 447
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, High Frequency (13 report gap)

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) sits #398 of 1000 among tracked device types with 3,110 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

Monitor, Cardiac carries 5.7% INJURY-coded reports, 24.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 18.5% corpus 1.5% · above corpus mean (+17.0 pp)
  • INJ 5.7% corpus 30.3% · below corpus mean (-24.6 pp)
  • MALF 71.5% corpus 64.8% · above corpus mean (+6.7 pp)

Lead product-problem code Unable to Obtain Readings is 19% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 47% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Monitor, Cardiac in the event-volume neighbourhood

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

reports

What this shows Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) carries 3,110 MAUDE reports, ranked #398 of 1000.

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

Event Types

Malfunction 2,225 (71.5%)
Death 575 (18.5%)
Injury 177 (5.7%)
Other 89 (2.9%)
44 (1.4%)

Patient Outcomes

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

2,145 (67.7%)
Death 553 (17.5%)
Other 222 (7.0%)
Life Threatening 87 (2.7%)
Required Intervention 83 (2.6%)
R 29 (0.9%)
Hospitalization 16 (0.5%)
O 13 (0.4%)
L 9 (0.3%)
S 4 (0.1%)
Congenital Anomaly 3 (0.1%)
D 1 (0.0%)
H 1 (0.0%)
Disability 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Unable to Obtain Readings 532
Device Alarm System 438
No Audible Alarm 201
Overheating of Device 196
Device Displays Incorrect Message 190
No Display/Image 162
Temperature Problem 149
Output Problem 132
Display or Visual Feedback Problem 90
Incorrect, Inadequate or Imprecise Result or Readings 90
Communication or Transmission Problem 81
Device Issue 77
Device Operates Differently Than Expected 76
Unknown (for use when the device problem is not known) 73
Loss of Power 72
Use of Device Problem 72
Monitor failure 62
Self-Activation or Keying 62
Other (for use when an appropriate device code cannot be identified) 55
Alarm, failure of warning 49

Yearly Trend

92
1992: 16
93
1993: 11
94
1994: 39
95
1995: 35
96
1996: 63
97
1997: 60
98
1998: 105
99
1999: 138
00
2000: 99
01
2001: 123
02
2002: 102
03
2003: 114
04
2004: 93
05
2005: 146
06
2006: 194
07
2007: 113
08
2008: 99
09
2009: 118
10
2010: 63
11
2011: 36
12
2012: 47
13
2013: 16
14
2014: 26
15
2015: 48
16
2016: 55
17
2017: 159
18
2018: 224
19
2019: 447
20
2020: 50
21
2021: 85
22
2022: 35
23
2023: 47
24
2024: 29
25
2025: 40
26
2026: 35

Reports in 2025 (40) held close to the prior two-year average of 38.

Related Entities for Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Top Manufacturers

ZOLL MEDICAL CORPORATION 665
NIHON KOHDEN CORPORATION 513
PHILIPS MEDICAL SYSTEMS 232

Event Locations

1,494 (48.0%)
HOSPITAL 800 (25.7%)
I 684 (22.0%)
INVALID DATA 48 (1.5%)
UNKNOWN 23 (0.7%)
NO INFORMATION 21 (0.7%)
OTHER 12 (0.4%)
OUTPATIENT TREATMENT FACILITY 10 (0.3%)
HOME 5 (0.2%)
NOT APPLICABLE 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
CRITICAL CARE UNIT 1 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)
MATERNITY WARD - NURSERY 1 (0.0%)

Compare ZOLL MEDICAL CORPORATION vs NIHON KOHDEN CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Monitor, Cardiac: 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 (3,110 here).

Ventilator, High Frequency 3,097 Joint, Temporomandibular, Implant 3,096 Prosthesis, Esophageal 3,094 Test, Hepatitis B 3,089

Similar death-typed counts

Nearest other device types by death-typed report count (575 here), distinct from the volume row.

Catheters 583 Intracranial Neurovascular Stent 537 Intracranial Aneurysm Flow Diverter 616 Drug-Eluting Peripheral Transluminal Angiop… 528

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

Disclaimer: MAUDE figures for Monitor, Cardiac 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 Monitor, Cardiac; 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.