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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Monitor, Cardiac LIGHT-BOOK · MAUDE

#383 of 1000 · 3,091 reports · 1992–2026

  • BOOK 3,091 reports
  • RANK #383 of 1000
  • DEATH 575 death-typed
  • INJ 177 injury-typed
  • MALF 2,206 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 447
  • PHOTO Collector

Nearest event-volume peer: Collector, Urine, Powered, Non Indwelling Catheter (1 report gap)

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) sits #383 of 1000 among tracked device types with 3,091 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 →

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 18.6% corpus 1.5% · above corpus mean (+17.1 pp)
  • INJ 5.7% corpus 30.4% · below corpus mean (-24.7 pp)
  • MALF 71.4% corpus 64.5% · above corpus mean (+6.9 pp)

Lead product-problem code Unable to Obtain Readings is 38% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 48% 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 3,091 MAUDE reports, ranked #383 of 1000.

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

Event Types

Malfunction 2,206 (71.4%)
Death 575 (18.6%)
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.

2,128 (67.6%)
Death 553 (17.6%)
Other 220 (7.0%)
Life Threatening 87 (2.8%)
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 519
Overheating of Device 171
Temperature Problem 137
Output Problem 120
Device Displays Incorrect Message 74
Incorrect, Inadequate or Imprecise Result or Readings 68
Communication or Transmission Problem 63
Failure of Device to Self-Test 23
Display or Visual Feedback Problem 21
Device Operates Differently Than Expected 19
Power Problem 18
Protective Measures Problem 18
Battery Problem 17
Misassembly by Users 16
Device Issue 15
Application Program Problem 13
No Audible Alarm 13
Patient Data Problem 13
Intermittent Communication Failure 12
No Display/Image 12

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: 16

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

Top Manufacturers

ZOLL MEDICAL CORPORATION 665
NIHON KOHDEN CORPORATION 498
PHILIPS MEDICAL SYSTEMS 232

Event Locations

1,476 (47.8%)
HOSPITAL 799 (25.8%)
I 684 (22.1%)
INVALID DATA 48 (1.6%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Monitor, Cardiac, 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 (3,091 here).

Collector 3,090 Stimulator 3,075 Unit, Cryosurgical, Accessories 3,107 Apparatus, Autotransfusion 3,115

Similar death-typed counts

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

Catheters 578 Intracranial Aneurysm Flow Diverter 600 Intracranial Neurovascular Stent 533 Tubes, Gastrointestinal 620

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.