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2026 data FDA MAUDE openFDA FDA Class II

Incubator, Neonatal

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 §880.5400 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Incubator, Neonatal LIGHT-BOOK · MAUDE

#713 of 1000 · 847 reports · 1992–2026

  • BOOK 847 reports
  • RANK #713 of 1000
  • DEATH 17 death-typed
  • INJ 105 injury-typed
  • MALF 667 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 254
  • PHOTO Dislodger

Nearest event-volume peer: Dislodger, Stone, Biliary (0 report gap)

Incubator, Neonatal sits #713 of 1000 among tracked device types with 847 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

Incubator, Neonatal carries 12.4% INJURY-coded reports, 17.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · above corpus mean (+0.5 pp)
  • INJ 12.4% corpus 30.3% · below corpus mean (-17.9 pp)
  • MALF 78.7% corpus 64.8% · above corpus mean (+13.9 pp)

Lead product-problem code Detachment of Device or Device Component is 28% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Incubator, Neonatal in the event-volume neighbourhood

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

reports

What this shows Incubator, Neonatal carries 847 MAUDE reports, ranked #713 of 1000.

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

Event Types

Malfunction 667 (78.7%)
Injury 105 (12.4%)
Other 40 (4.7%)
18 (2.1%)
Death 17 (2.0%)

Patient Outcomes

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

649 (76.3%)
Other 109 (12.8%)
Required Intervention 47 (5.5%)
Death 18 (2.1%)
Life Threatening 10 (1.2%)
Hospitalization 9 (1.1%)
O 3 (0.4%)
R 2 (0.2%)
Disability 2 (0.2%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Detachment of Device or Device Component 187
No Flow 101
Break 69
Insufficient Flow or Under Infusion 61
Adverse Event Without Identified Device or Use Problem 25
Overheating of Device 24
Unknown (for use when the device problem is not known) 22
Use of Device Problem 20
Device Alarm System 19
Mechanical Problem 18
Microbial Contamination of Device 17
Smoking 17
Replace 16
Device Displays Incorrect Message 14
Device Emits Odor 14
Appropriate Device Problem Term/Code Not Available 11
Infusion or Flow Problem 10
Insufficient Device Problem Information 10
Loose 10
Design/structure problem 8

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 5
95
1995: 2
96
1996: 8
97
1997: 15
98
1998: 18
99
1999: 19
00
2000: 3
01
2001: 8
02
2002: 10
03
2003: 9
04
2004: 20
05
2005: 14
06
2006: 11
07
2007: 14
08
2008: 10
09
2009: 8
10
2010: 11
11
2011: 10
12
2012: 12
13
2013: 11
14
2014: 3
15
2015: 9
16
2016: 12
17
2017: 4
18
2018: 18
19
2019: 24
20
2020: 8
21
2021: 15
22
2022: 27
23
2023: 19
24
2024: 118
25
2025: 254
26
2026: 112

Reports rose to 254 in 2025, up from an average of 69 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Incubator, Neonatal

Top Manufacturers

DATEX-OHMEDA, INC. 278

Event Locations

644 (76.0%)
HOSPITAL 119 (14.0%)
I 48 (5.7%)
NO INFORMATION 14 (1.7%)
NOT APPLICABLE 13 (1.5%)
INVALID DATA 6 (0.7%)
UNKNOWN 2 (0.2%)
OTHER 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Incubator, Neonatal: 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 (847 here).

Dislodger, Stone, Biliary 847 Posterior Metal/Polymer Spinal System 848 Instruments, Surgical, Cardiovascular 845 Tubing, Fluid Delivery 850

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17 Counter, Differential Cell 17

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

Disclaimer: MAUDE figures for Incubator, Neonatal 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 Incubator, Neonatal; 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.