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2026 data FDA MAUDE openFDA FDA Class II

System, Measurement, Blood-Pressure, Non-Invasive

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 §870.1130 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#391 of 1000 · 3,169 reports · 1992–2026

  • BOOK 3,169 reports
  • RANK #391 of 1000
  • DEATH 16 death-typed
  • INJ 298 injury-typed
  • MALF 2,773 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 711
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Autotransfusion (6 report gap)

System, Measurement, Blood-Pressure, Non-Invasive sits #391 of 1000 among tracked device types with 3,169 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 →

Malfunction reports run above the device-type norm

System carries 87.5% MALFUNCTION-coded reports, 22.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 9.4% corpus 30.3% · below corpus mean (-20.9 pp)
  • MALF 87.5% corpus 64.8% · above corpus mean (+22.7 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 18% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 50% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Measurement, Blood-Pressure, Non-Invasive carries 3,169 MAUDE reports, ranked #391 of 1000.

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

Event Types

Malfunction 2,773 (87.5%)
Injury 298 (9.4%)
Other 42 (1.3%)
40 (1.3%)
Death 16 (0.5%)

Patient Outcomes

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

2,652 (84.9%)
Other 209 (6.7%)
Required Intervention 81 (2.6%)
Hospitalization 73 (2.3%)
R 29 (0.9%)
Life Threatening 20 (0.6%)
Death 14 (0.4%)
O 13 (0.4%)
Disability 11 (0.4%)
L 9 (0.3%)
S 5 (0.2%)
H 4 (0.1%)
Invalid Data 4 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 646
Device Operational Issue 391
Fluid/Blood Leak 339
Device Operates Differently Than Expected 283
Device Displays Incorrect Message 278
Output Problem 258
High Readings 215
Incorrect Or Inadequate Test Results 181
Incorrect Measurement 160
High Test Results 143
Failure to Power Up 117
Inflation Problem 108
Low Readings 94
Image Display Error/Artifact 80
Unable to Obtain Readings 71
Insufficient Device Problem Information 56
No Audible Alarm 56
No Audible Prompt/Feedback 45
Failure to Deflate 42
Defective Device 37

Yearly Trend

92
1992: 4
93
1993: 6
94
1994: 6
95
1995: 17
96
1996: 23
97
1997: 25
98
1998: 16
99
1999: 12
00
2000: 6
01
2001: 11
02
2002: 13
03
2003: 10
04
2004: 16
05
2005: 36
06
2006: 6
07
2007: 21
08
2008: 8
09
2009: 17
10
2010: 14
11
2011: 10
12
2012: 19
13
2013: 72
14
2014: 47
15
2015: 62
16
2016: 54
17
2017: 90
18
2018: 617
19
2019: 96
20
2020: 130
21
2021: 162
22
2022: 155
23
2023: 162
24
2024: 270
25
2025: 245
26
2026: 711

Reports in 2025 (245) held close to the prior two-year average of 216.

Related Entities for System, Measurement, Blood-Pressure, Non-Invasive

Top Manufacturers

MEDLINE INDUSTRIES, LP 471
PHILIPS MEDICAL SYSTEMS 340
EDWARDS LIFESCIENCES 140

Event Locations

1,819 (57.4%)
I 1,076 (34.0%)
HOSPITAL 121 (3.8%)
HOME 51 (1.6%)
NO INFORMATION 41 (1.3%)
UNKNOWN 23 (0.7%)
INVALID DATA 14 (0.4%)
OTHER 9 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
NOT APPLICABLE 2 (0.1%)
NURSING HOME 1 (0.0%)

Compare MEDLINE INDUSTRIES, LP vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: 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 (3,169 here).

Apparatus, Autotransfusion 3,163 Dilator 3,156 Endoscopic Tissue Approximation Device 3,154 Test, Hiv Detection 3,187

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Catheter And Tip, Suction 16 Computer 16 Dilator, Esophageal 16 Implanted Subcortical Electrical Stimulator 16

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

Disclaimer: MAUDE figures for System 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 System; 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.