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2026 data FDA MAUDE openFDA

Computer, Blood-Pressure

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 Computer, Blood-Pressure LIGHT-BOOK · MAUDE

#859 of 1000 · 516 reports · 1993–2026

  • BOOK 516 reports
  • RANK #859 of 1000
  • DEATH 3 death-typed
  • INJ 30 injury-typed
  • MALF 482 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 148
  • PHOTO System

Nearest event-volume peer: System, Test, Rheumatoid Factor (1 report gap)

Computer, Blood-Pressure sits #859 of 1000 among tracked device types with 516 MAUDE reports spanning 1993–2026. 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 5.8% corpus 30.4% · below corpus mean (-24.6 pp)
  • MALF 93.4% corpus 64.5% · above corpus mean (+28.9 pp)

Lead product-problem code Fluid/Blood Leak is 64% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 67% of manufacturer-tagged reports · Top event location I is 60% of location-tagged rows .

Computer, Blood-Pressure in the event-volume neighbourhood

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

reports

What this shows Computer, Blood-Pressure carries 516 MAUDE reports, ranked #859 of 1000.

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

Event Types

Malfunction 482 (93.4%)
Injury 30 (5.8%)
Death 3 (0.6%)
1 (0.2%)

Patient Outcomes

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

484 (91.5%)
Life Threatening 14 (2.6%)
Required Intervention 9 (1.7%)
R 8 (1.5%)
L 3 (0.6%)
Death 3 (0.6%)
Hospitalization 3 (0.6%)
Other 3 (0.6%)
O 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Fluid/Blood Leak 256
Leak/Splash 62
Material Separation 24
Pressure Problem 10
Incomplete or Inadequate Connection 6
Device Operates Differently Than Expected 5
Fracture 5
No Device Output 5
No Audible Prompt/Feedback 4
Crack 3
Loose or Intermittent Connection 3
Low Readings 3
No Audible Alarm 3
Display or Visual Feedback Problem 2
Incorrect Measurement 2
Incorrect, Inadequate or Imprecise Result or Readings 2
No Display/Image 2
Unable to Obtain Readings 2
Adverse Event Without Identified Device or Use Problem 1
Air Leak 1

Yearly Trend

93
1993: 1
94
1994: 2
96
1996: 1
97
1997: 1
98
1998: 1
03
2003: 1
10
2010: 10
11
2011: 5
12
2012: 69
13
2013: 5
14
2014: 8
15
2015: 7
16
2016: 13
17
2017: 6
18
2018: 93
19
2019: 148
20
2020: 29
21
2021: 31
22
2022: 29
23
2023: 14
24
2024: 12
25
2025: 26
26
2026: 4

Related Entities for Computer, Blood-Pressure

Top Manufacturers

ZOLL MEDICAL CORPORATION 80
PHILIPS MEDICAL SYSTEMS 12
TERUMO CARDIOVASCULAR SYSTEMS CORP. 11
ZOLL MEDICAL CORP 9
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 8

Event Locations

I 312 (60.5%)
193 (37.4%)
NO INFORMATION 5 (1.0%)
HOSPITAL 2 (0.4%)
INVALID DATA 2 (0.4%)
OTHER 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare ZOLL MEDICAL CORPORATION vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Computer, Blood-Pressure, 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 (516 here).

System, Test, Rheumatoid Factor 517 Instruments, Dental Hand 513 Percutaneously Delivered Prostheses And Tri… 519 Mask, Surgical 512

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Computer, Blood-Pressure 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 Computer, Blood-Pressure; 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.