2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#105 of 1000 · 29,993 reports · 1992–2026

  • BOOK 29,993 reports
  • RANK #105 of 1000
  • DEATH 1,857 death-typed
  • INJ 3,148 injury-typed
  • MALF 24,724 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 3,813
  • PHOTO Dialysate Concentrate…

Nearest event-volume peer: Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (81 report gap)

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) sits #105 of 1000 among tracked device types with 29,993 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 6.2% corpus 1.5% · above corpus mean (+4.7 pp)
  • INJ 10.5% corpus 30.4% · below corpus mean (-19.9 pp)
  • MALF 82.4% corpus 64.5% · above corpus mean (+17.9 pp)

Lead product-problem code No Audible Alarm is 16% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 53% of manufacturer-tagged reports · Top event location is 64% 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 29,993 MAUDE reports, ranked #105 of 1000.

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

Event Types

Malfunction 24,724 (82.4%)
Injury 3,148 (10.5%)
Death 1,857 (6.2%)
Other 137 (0.5%)
126 (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.

25,723 (84.7%)
Death 1,818 (6.0%)
Other 1,442 (4.7%)
Required Intervention 561 (1.8%)
Life Threatening 307 (1.0%)
R 284 (0.9%)
O 74 (0.2%)
Hospitalization 66 (0.2%)
L 35 (0.1%)
Disability 22 (0.1%)
D 14 (0.0%)
S 10 (0.0%)
Congenital Anomaly 7 (0.0%)
C 1 (0.0%)
H 1 (0.0%)

Top Product Problems

No Audible Alarm 2,887
Patient Device Interaction Problem 1,523
Device Alarm System 1,454
Communication or Transmission Problem 1,432
No Audible Prompt/Feedback 980
Defective Alarm 914
Output Problem 892
Display or Visual Feedback Problem 874
Application Program Problem 785
Nonstandard Device 754
No Display/Image 753
Device Operates Differently Than Expected 735
Device Displays Incorrect Message 576
Unable to Obtain Readings 559
Computer Operating System Problem 519
Unintended Application Program Shut Down 516
Adverse Event Without Identified Device or Use Problem 508
Power Problem 483
Application Program Freezes, Becomes Nonfunctional 440
Unexpected Shutdown 430

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: 747

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

Event Locations

19,233 (64.1%)
I 6,358 (21.2%)
HOSPITAL 4,200 (14.0%)
NO INFORMATION 135 (0.5%)
AMBULATORY SURGICAL FACILITY 25 (0.1%)
OTHER 18 (0.1%)
INVALID DATA 13 (0.0%)
UNKNOWN 4 (0.0%)
HOME 3 (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 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 (29,993 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,857 here), distinct from the volume row.

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.