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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#436 of 1000 · 2,503 reports · 1992–2026

  • BOOK 2,503 reports
  • RANK #436 of 1000
  • DEATH 15 death-typed
  • INJ 291 injury-typed
  • MALF 2,115 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 617
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Conduction, Anesthetic (5 report gap)

System, Measurement, Blood-Pressure, Non-Invasive sits #436 of 1000 among tracked device types with 2,503 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 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 11.6% corpus 30.4% · below corpus mean (-18.8 pp)
  • MALF 84.5% corpus 64.5% · above corpus mean (+20.0 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 18% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 71% of manufacturer-tagged reports · Top event location is 46% 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 2,503 MAUDE reports, ranked #436 of 1000.

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

Event Types

Malfunction 2,115 (84.5%)
Injury 291 (11.6%)
Other 42 (1.7%)
40 (1.6%)
Death 15 (0.6%)

Patient Outcomes

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

2,101 (82.1%)
Other 199 (7.8%)
Required Intervention 78 (3.0%)
Hospitalization 70 (2.7%)
R 29 (1.1%)
Life Threatening 20 (0.8%)
Death 14 (0.5%)
O 13 (0.5%)
Disability 11 (0.4%)
L 9 (0.4%)
S 5 (0.2%)
H 4 (0.2%)
Invalid Data 4 (0.2%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 523
Device Operational Issue 391
Fluid/Blood Leak 320
Device Displays Incorrect Message 251
Output Problem 238
Device Operates Differently Than Expected 232
Incorrect Or Inadequate Test Results 177
Incorrect Measurement 127
High Test Results 125
High Readings 102
Low Readings 62
No Audible Alarm 46
No Audible Prompt/Feedback 45
Insufficient Information 43
Failure to Deflate 42
Defective Device 33
Smoking 28
Fracture 27
No Device Output 27
Inflation Problem 24

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: 45

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

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 336
EDWARDS LIFESCIENCES 138

Event Locations

1,154 (46.1%)
I 1,076 (43.0%)
HOSPITAL 121 (4.8%)
HOME 50 (2.0%)
NO INFORMATION 41 (1.6%)
UNKNOWN 23 (0.9%)
INVALID DATA 14 (0.6%)
OTHER 9 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
NOT APPLICABLE 2 (0.1%)
NURSING HOME 1 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS vs EDWARDS LIFESCIENCES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, 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 (2,503 here).

Catheter, Conduction, Anesthetic 2,498 Aid, Transfer 2,510 Real Time Nucleic Acid Amplification System 2,522 Handpiece 2,523

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Catheter 15 Guide, Wire, Catheter, Neurovasculature 15 Infusor, Pressure, For I.V. Bags 15 Posterior Cervical Screw System 15

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.