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2026 data FDA MAUDE openFDA FDA Class II

Monitor, Physiological, Patient(With 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 §870.1025 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#105 of 1000 · 32,228 reports · 1992–2026

  • BOOK 32,228 reports
  • RANK #105 of 1000
  • DEATH 1,909 death-typed
  • INJ 3,567 injury-typed
  • MALF 26,489 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 3,813
  • PHOTO Protector, Ostomy

Nearest event-volume peer: Protector, Ostomy (26 report gap)

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) sits #105 of 1000 among tracked device types with 32,228 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, Physiological, Patient carries 11.1% INJURY-coded reports, 19.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.9% corpus 1.5% · above corpus mean (+4.4 pp)
  • INJ 11.1% corpus 30.3% · below corpus mean (-19.2 pp)
  • MALF 82.2% corpus 64.8% · above corpus mean (+17.4 pp)

Lead product-problem code No Audible Alarm is 14% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 52% of manufacturer-tagged reports · Top event location is 67% 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(With Arrhythmia Detection Or Alarms) carries 32,228 MAUDE reports, ranked #105 of 1000.

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

Event Types

Malfunction 26,489 (82.2%)
Injury 3,567 (11.1%)
Death 1,909 (5.9%)
Other 137 (0.4%)
125 (0.4%)
No answer provided 1 (0.0%)

Patient Outcomes

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

27,702 (85.0%)
Death 1,863 (5.7%)
Other 1,587 (4.9%)
Required Intervention 586 (1.8%)
Life Threatening 319 (1.0%)
R 287 (0.9%)
O 75 (0.2%)
Hospitalization 71 (0.2%)
L 36 (0.1%)
Disability 23 (0.1%)
D 15 (0.0%)
S 10 (0.0%)
Congenital Anomaly 8 (0.0%)
C 1 (0.0%)
H 1 (0.0%)

Top Product Problems

No Audible Alarm 3,690
Device Operates Differently Than Expected 3,051
Device Alarm System 2,632
Communication or Transmission Problem 1,947
Patient Device Interaction Problem 1,875
Device Displays Incorrect Message 1,420
No Display/Image 1,352
Device Inoperable 1,177
No Audible Prompt/Feedback 1,108
Defective Alarm 1,099
Display or Visual Feedback Problem 1,047
Output Problem 1,010
Application Program Problem 868
Nonstandard Device 838
Unable to Obtain Readings 729
Computer Operating System Problem 607
Unintended Application Program Shut Down 600
Adverse Event Without Identified Device or Use Problem 584
Incorrect Measurement 532
Power Problem 517

Yearly Trend

92
1992: 4
93
1993: 3
94
1994: 7
95
1995: 9
96
1996: 32
97
1997: 42
98
1998: 28
99
1999: 21
00
2000: 30
01
2001: 60
02
2002: 43
03
2003: 82
04
2004: 79
05
2005: 84
06
2006: 184
07
2007: 131
08
2008: 232
09
2009: 382
10
2010: 955
11
2011: 948
12
2012: 673
13
2013: 1,997
14
2014: 1,609
15
2015: 1,284
16
2016: 1,105
17
2017: 1,115
18
2018: 2,157
19
2019: 1,462
20
2020: 1,714
21
2021: 2,423
22
2022: 1,470
23
2023: 2,254
24
2024: 2,814
25
2025: 3,813
26
2026: 2,982

Reports rose to 3,813 in 2025, up from an average of 2,534 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 9,066
NIHON KOHDEN CORPORATION 5,222
ZOLL MANUFACTURING CORPORATION 2,165
PHILIPS NORTH AMERICA LLC 861

Event Locations

21,447 (66.5%)
I 6,356 (19.7%)
HOSPITAL 4,222 (13.1%)
NO INFORMATION 135 (0.4%)
AMBULATORY SURGICAL FACILITY 25 (0.1%)
OTHER 18 (0.1%)
INVALID DATA 13 (0.0%)
HOME 4 (0.0%)
UNKNOWN 4 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS vs NIHON KOHDEN CORPORATION →

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 (32,228 here).

Protector, Ostomy 32,254 Prosthesis 32,652 Pump, Infusion, Pca 32,663 Bronchoscope 31,113

Similar death-typed counts

Nearest other device types by death-typed report count (1,909 here), distinct from the volume row.

Stimulator 1,904 Implantable Pacemaker Pulse-Generator 1,952 Drug Eluting Permanent Left Ventricular Pac… 1,856 Implantable Pulse Generator, Pacemaker 1,854

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.