2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1110 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Computer, Blood-Pressure LIGHT-BOOK · MAUDE

#862 of 1000 · 546 reports · 1993–2026

  • BOOK 546 reports
  • RANK #862 of 1000
  • DEATH 3 death-typed
  • INJ 31 injury-typed
  • MALF 511 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 148
  • PHOTO Method

Nearest event-volume peer: Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (1 report gap)

Computer, Blood-Pressure sits #862 of 1000 among tracked device types with 546 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 →

Malfunction reports run above the device-type norm

Computer, Blood-Pressure carries 93.6% MALFUNCTION-coded reports, 28.8pp 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 5.7% corpus 30.3% · below corpus mean (-24.6 pp)
  • MALF 93.6% corpus 64.8% · above corpus mean (+28.8 pp)

Lead product-problem code Fluid/Blood Leak is 54% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 63% of manufacturer-tagged reports · Top event location I is 57% 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 546 MAUDE reports, ranked #862 of 1000.

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

Event Types

Malfunction 511 (93.6%)
Injury 31 (5.7%)
Death 3 (0.5%)
1 (0.2%)

Patient Outcomes

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

511 (91.7%)
Life Threatening 14 (2.5%)
Required Intervention 10 (1.8%)
R 8 (1.4%)
L 3 (0.5%)
Death 3 (0.5%)
Hospitalization 3 (0.5%)
Other 3 (0.5%)
O 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Fluid/Blood Leak 273
Leak/Splash 62
Device Displays Incorrect Message 29
Material Separation 24
Failure to Power Up 22
Device Operates Differently Than Expected 20
No Display/Image 14
Pressure Problem 12
No Device Output 7
Fracture 6
Incomplete or Inadequate Connection 6
No Audible Prompt/Feedback 6
Device Inoperable 4
Incorrect Measurement 4
Low Readings 4
No Audible Alarm 4
Crack 3
Failure to Charge 3
Failure to Discharge 3
Loose or Intermittent Connection 3

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: 34

Reports rose to 26 in 2025, up from an average of 13 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Computer, Blood-Pressure

Event Locations

I 312 (57.1%)
223 (40.8%)
NO INFORMATION 5 (0.9%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Computer, Blood-Pressure: 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 (546 here).

Similar death-typed counts

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

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.