PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Suction, Patient Care

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 §870.5050 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Apparatus, Suction, Patient Care LIGHT-BOOK · MAUDE

#637 of 1000 · 1,122 reports · 1992–2026

  • BOOK 1,122 reports
  • RANK #637 of 1000
  • DEATH 24 death-typed
  • INJ 253 injury-typed
  • MALF 739 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 143
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Hemi-, Femoral, Metal Ball (2 report gap)

Apparatus, Suction, Patient Care sits #637 of 1000 among tracked device types with 1,122 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 →

Injury-coded reports sit below the device-type norm

Apparatus, Suction, Patient Care carries 22.5% INJURY-coded reports, 7.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 22.5% corpus 30.3% · below corpus mean (-7.7 pp)
  • MALF 65.9% corpus 64.8% · above corpus mean (+1.0 pp)

Lead product-problem code Break is 24% of coded problems · Lead manufacturer CAREFUSION, INC accounts for 74% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Apparatus, Suction, Patient Care in the event-volume neighbourhood

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

reports

What this shows Apparatus, Suction, Patient Care carries 1,122 MAUDE reports, ranked #637 of 1000.

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

Event Types

Malfunction 739 (65.9%)
Injury 253 (22.5%)
103 (9.2%)
Death 24 (2.1%)
Other 3 (0.3%)

Patient Outcomes

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

Other 617 (53.4%)
273 (23.6%)
Required Intervention 172 (14.9%)
Death 27 (2.3%)
Hospitalization 25 (2.2%)
R 18 (1.6%)
Life Threatening 7 (0.6%)
O 6 (0.5%)
L 5 (0.4%)
H 4 (0.3%)
D 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Break 217
Adverse Event Without Identified Device or Use Problem 74
Fluid/Blood Leak 73
Material Separation 63
Detachment of Device or Device Component 62
Leak/Splash 61
Suction Problem 39
Fracture 38
Detachment Of Device Component 32
Disconnection 29
Sharp Edges 27
Device Operates Differently Than Expected 25
Material Puncture/Hole 25
Device Inoperable 24
Product Quality Problem 24
Complete Blockage 22
Crack 22
Device Dislodged or Dislocated 21
Unsealed Device Packaging 20
Contamination 16

Yearly Trend

92
1992: 4
93
1993: 2
95
1995: 1
99
1999: 2
03
2003: 3
05
2005: 1
06
2006: 1
07
2007: 2
08
2008: 2
09
2009: 2
10
2010: 8
11
2011: 23
12
2012: 16
13
2013: 78
14
2014: 94
15
2015: 82
16
2016: 49
17
2017: 62
18
2018: 51
19
2019: 57
20
2020: 68
21
2021: 143
22
2022: 62
23
2023: 108
24
2024: 70
25
2025: 74
26
2026: 57

Reports in 2025 (74) held close to the prior two-year average of 89.

Related Entities for Apparatus, Suction, Patient Care

Top Manufacturers

CAREFUSION, INC 541
CAREFUSION 145
BARD ACCESS SYSTEMS 26
MERIT MEDICAL SYSTEMS, INC. 24

Event Locations

640 (57.0%)
I 390 (34.8%)
HOSPITAL 61 (5.4%)
NO INFORMATION 16 (1.4%)
HOME 9 (0.8%)
OTHER 2 (0.2%)
HOSPICE 1 (0.1%)
INVALID DATA 1 (0.1%)
NURSING HOME 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare CAREFUSION, INC vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus, Suction, Patient Care: 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 (1,122 here).

Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,120 Intervertebral Fusion Device With Bone Graft 1,117 Epidural Anesthesia Kit 1,130 Pulmonic Valved Conduit 1,133

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Catheter, Oximeter, Fiber-Optic 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24 Mesh 24

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

Disclaimer: MAUDE figures for Apparatus, Suction, Patient Care 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 Apparatus, Suction, Patient Care; 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.