2025 data FDA MAUDE openFDA FDA Class II

Manometer, Spinal-Fluid

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 §880.2500 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Manometer, Spinal-Fluid LIGHT-BOOK · MAUDE

#958 of 1000 · 411 reports · 1999–2025

  • BOOK 411 reports
  • RANK #958 of 1000
  • DEATH 1 death-typed
  • INJ 11 injury-typed
  • MALF 399 malfunction
  • SPAN 1999–2025
  • PEAK 2014: 176
  • PHOTO Mass Spectrometry

Nearest event-volume peer: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (0 report gap)

Manometer, Spinal-Fluid sits #958 of 1000 among tracked device types with 411 MAUDE reports spanning 1999–2025. 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

Manometer, Spinal-Fluid carries 97.1% MALFUNCTION-coded reports, 32.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 2.7% corpus 30.3% · below corpus mean (-27.6 pp)
  • MALF 97.1% corpus 64.8% · above corpus mean (+32.3 pp)

Lead product-problem code Detachment Of Device Component is 65% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 88% of manufacturer-tagged reports · Top event location HOSPITAL is 76% of location-tagged rows .

Manometer, Spinal-Fluid in the event-volume neighbourhood

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

reports

What this shows Manometer, Spinal-Fluid carries 411 MAUDE reports, ranked #958 of 1000.

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

Event Types

Malfunction 399 (97.1%)
Injury 11 (2.7%)
Death 1 (0.2%)

Patient Outcomes

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

393 (95.4%)
Other 9 (2.2%)
Required Intervention 8 (1.9%)
O 1 (0.2%)
Death 1 (0.2%)

Top Product Problems

Detachment Of Device Component 368
Needle, separation 152
Disengaged 9
Fail-Safe Design Failure 6
Fluid/Blood Leak 6
Component(s), broken 5
Difficult or Delayed Activation 3
Bent 2
Difficult to Remove 2
Failure to Capture 2
Leak/Splash 2
Tip breakage 2
Unable to Obtain Readings 2
Valve(s), defective 2
Activation, Positioning or Separation Problem 1
Adverse Event Without Identified Device or Use Problem 1
Break 1
Complete Blockage 1
Connection Problem 1
Device, or device fragments remain in patient 1

Yearly Trend

99
1999: 3
00
2000: 2
01
2001: 2
02
2002: 2
07
2007: 1
09
2009: 1
10
2010: 7
11
2011: 1
12
2012: 28
13
2013: 101
14
2014: 176
15
2015: 84
19
2019: 1
23
2023: 1
25
2025: 1

Reports fell to 1 in 2023, down from an average of 43 in the two years before.

Related Entities for Manometer, Spinal-Fluid

Event Locations

HOSPITAL 313 (76.2%)
OTHER 84 (20.4%)
11 (2.7%)
HOME 1 (0.2%)
I 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare SMITHS MEDICAL ASD, INC. vs SMITHS MEDICAL ASD, INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Manometer, Spinal-Fluid: 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 (411 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Manometer, Spinal-Fluid 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 Manometer, Spinal-Fluid; 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.