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2026 data FDA MAUDE openFDA FDA Class II

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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, Physiological, Patient LIGHT-BOOK · MAUDE

#505 of 1000 · 1,983 reports · 2001–2026

  • BOOK 1,983 reports
  • RANK #505 of 1000
  • DEATH 45 death-typed
  • INJ 114 injury-typed
  • MALF 1,805 malfunction
  • SPAN 2001–2026
  • PEAK 2026: 355
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Total Triiodothyronine (4 report gap)

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) sits #505 of 1000 among tracked device types with 1,983 MAUDE reports spanning 2001–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Monitor, Physiological, Patient carries 91.0% MALFUNCTION-coded reports, 26.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 5.7% corpus 30.3% · below corpus mean (-24.5 pp)
  • MALF 91.0% corpus 64.8% · above corpus mean (+26.2 pp)

Lead product-problem code Incorrect Measurement is 15% of coded problems · Top event location is 62% of location-tagged rows .

Monitor, Physiological, Patient in the event-volume neighbourhood

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

reports

What this shows Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) carries 1,983 MAUDE reports, ranked #505 of 1000.

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

Event Types

Malfunction 1,805 (91.0%)
Injury 114 (5.7%)
Death 45 (2.3%)
Other 11 (0.6%)
8 (0.4%)

Patient Outcomes

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

1,763 (89.5%)
Other 82 (4.2%)
Death 44 (2.2%)
Required Intervention 43 (2.2%)
Hospitalization 14 (0.7%)
R 7 (0.4%)
Life Threatening 6 (0.3%)
L 5 (0.3%)
O 2 (0.1%)
D 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Incorrect Measurement 234
Unexpected Shutdown 214
Device Alarm System 107
No Audible Alarm 100
High Readings 89
Sensing Intermittently 87
Display or Visual Feedback Problem 79
Incorrect, Inadequate or Imprecise Result or Readings 67
Inappropriate or Unexpected Reset 59
Device Operates Differently Than Expected 53
Device Displays Incorrect Message 52
Failure to Power Up 51
Insufficient Device Problem Information 45
Application Program Freezes or Fails to Launch 43
Break 43
Low Readings 43
Unable to Obtain Readings 41
Communication or Transmission Problem 40
Overheating of Device 40
Sparking 36

Yearly Trend

01
2001: 3
02
2002: 1
03
2003: 3
04
2004: 2
05
2005: 6
06
2006: 8
07
2007: 3
08
2008: 3
09
2009: 20
10
2010: 17
11
2011: 16
12
2012: 31
13
2013: 42
14
2014: 30
15
2015: 31
16
2016: 51
17
2017: 85
18
2018: 158
19
2019: 169
20
2020: 110
21
2021: 188
22
2022: 168
23
2023: 179
24
2024: 120
25
2025: 184
26
2026: 355

Reports in 2025 (184) held close to the prior two-year average of 150.

Related Entities for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Event Locations

1,232 (62.1%)
I 650 (32.8%)
HOSPITAL 78 (3.9%)
NO INFORMATION 18 (0.9%)
OTHER 3 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Monitor, Physiological, 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.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,983 here).

Radioimmunoassay, Total Triiodothyronine 1,979 Tourniquet, Pneumatic 1,989 Trocar 1,994 Tubes, Vacuum Sample, With Anticoagulant 1,965

Similar death-typed counts

Nearest other device types by death-typed report count (45 here), distinct from the volume row.

Filler 45 Glue, Surgical, Arteries 45 System, Ablation, Microwave And Accessories 45 Catheter, Peritoneal, Long-Term Indwelling 46

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

Disclaimer: MAUDE figures for Monitor, Physiological, 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 Monitor, Physiological, 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.