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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Monitor, Physiological, Patient LIGHT-BOOK · MAUDE

#528 of 1000 · 1,663 reports · 2001–2026

  • BOOK 1,663 reports
  • RANK #528 of 1000
  • DEATH 44 death-typed
  • INJ 108 injury-typed
  • MALF 1,492 malfunction
  • SPAN 2001–2026
  • PEAK 2021: 188
  • PHOTO Adhesive

Nearest event-volume peer: Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer (0 report gap)

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) sits #528 of 1000 among tracked device types with 1,663 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 →

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 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 6.5% corpus 30.4% · below corpus mean (-23.9 pp)
  • MALF 89.7% corpus 64.5% · above corpus mean (+25.2 pp)

Lead product-problem code Incorrect Measurement is 17% of coded problems · Top event location is 55% 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 1,663 MAUDE reports, ranked #528 of 1000.

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

Event Types

Malfunction 1,492 (89.7%)
Injury 108 (6.5%)
Death 44 (2.6%)
Other 11 (0.7%)
8 (0.5%)

Patient Outcomes

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

1,481 (88.4%)
Other 73 (4.4%)
Death 44 (2.6%)
Required Intervention 42 (2.5%)
Hospitalization 14 (0.8%)
R 6 (0.4%)
L 5 (0.3%)
Life Threatening 5 (0.3%)
O 2 (0.1%)
D 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Incorrect Measurement 186
Unexpected Shutdown 115
High Readings 76
Sensing Intermittently 71
No Audible Alarm 66
Display or Visual Feedback Problem 65
Device Alarm System 58
Inappropriate or Unexpected Reset 54
Failure to Power Up 49
Incorrect, Inadequate or Imprecise Result or Readings 49
Device Displays Incorrect Message 45
Communication or Transmission Problem 38
Application Program Freezes, Becomes Nonfunctional 36
Sparking 34
Output Problem 33
Intermittent Loss of Power 31
Key or Button Unresponsive/not Working 31
Pitted 30
Overheating of Device 29
Unable to Obtain Readings 29

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: 35

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

Event Locations

913 (54.9%)
I 650 (39.1%)
HOSPITAL 77 (4.6%)
NO INFORMATION 18 (1.1%)
OTHER 3 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Monitor, Physiological, Patient, 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 (1,663 here).

Adhesive 1,663 Sleeve, Limb, Compressible 1,664 Apparatus 1,667 Marker, Radiographic, Implantable 1,671

Similar death-typed counts

Nearest other device types by death-typed report count (44 here), distinct from the volume row.

Catheter, Peritoneal, Long-Term Indwelling 44 Filler, Bone Void, Calcium Compound 44 System, Ablation, Microwave And Accessories 44 System, Hypothermia, Intravenous, Cooling 44

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.