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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Incubator, Neonatal LIGHT-BOOK · MAUDE

#735 of 1000 · 764 reports · 1992–2026

  • BOOK 764 reports
  • RANK #735 of 1000
  • DEATH 17 death-typed
  • INJ 102 injury-typed
  • MALF 587 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 254
  • PHOTO Electrocautery

Nearest event-volume peer: Electrocautery, Gynecologic (And Accessories) (1 report gap)

Incubator, Neonatal sits #735 of 1000 among tracked device types with 764 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 →

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 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 13.4% corpus 30.4% · below corpus mean (-17.1 pp)
  • MALF 76.8% corpus 64.5% · above corpus mean (+12.3 pp)

Lead product-problem code Detachment of Device or Device Component is 36% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 74% 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 764 MAUDE reports, ranked #735 of 1000.

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

Event Types

Malfunction 587 (76.8%)
Injury 102 (13.4%)
Other 40 (5.2%)
18 (2.4%)
Death 17 (2.2%)

Patient Outcomes

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

571 (74.2%)
Other 108 (14.0%)
Required Intervention 46 (6.0%)
Death 18 (2.3%)
Hospitalization 9 (1.2%)
Life Threatening 9 (1.2%)
O 3 (0.4%)
R 2 (0.3%)
Disability 2 (0.3%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Detachment of Device or Device Component 169
No Flow 70
Insufficient Flow or Under Infusion 54
Break 49
Adverse Event Without Identified Device or Use Problem 23
Microbial Contamination of Device 13
Mechanical Problem 12
Appropriate Term/Code Not Available 10
Infusion or Flow Problem 10
Therapeutic or Diagnostic Output Failure 8
Contamination /Decontamination Problem 7
Calibration Problem 6
Contamination 6
Gas/Air Leak 6
Device Displays Incorrect Message 5
Excessive Heating 5
Insufficient Heating 5
Insufficient Information 5
Loose or Intermittent Connection 4
Temperature Problem 4

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: 29

Related Entities for Incubator, Neonatal

Top Manufacturers

DATEX-OHMEDA, INC. 240

Event Locations

563 (73.7%)
HOSPITAL 117 (15.3%)
I 48 (6.3%)
NO INFORMATION 14 (1.8%)
NOT APPLICABLE 13 (1.7%)
INVALID DATA 6 (0.8%)
UNKNOWN 2 (0.3%)
OTHER 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Incubator, Neonatal, 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 (764 here).

Electrocautery, Gynecologic 765 Electrosurgical 763 Table, Radiographic, Tilting 762 Tray 762

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 Agent, Occluding, Vascular, Permanent 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 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.