DATEX-OHMEDA, INC.

Manufacturer adverse-event records for DATEX-OHMEDA, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1999–2026 · heavy-book · typical Death-code · injury-light

Injury-mix signature

DATEX-OHMEDA, INC. is lighter on Injury codes

Injury-coded event_type share is 0.4% (injury-light tercile) beside 0.10% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for DATEX-OHMEDA, INC.

The standout signal for DATEX-OHMEDA, INC. is Injury-mix: 0.4% Injury-coded (injury-light) beside 0.10% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair DATEX-OHMEDA, INC. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 48,219 (99.4% of event_type total). Peak single-year volume reaches 10,086 reports across 26 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

48,497
Total Reports
47
Event-type Death
207
Injury Reports
20
Device Types

Event Types

Malfunction 48,219 (99.4%)
Injury 207 (0.4%)
Death 47 (0.1%)
17 (0.0%)
Other 7 (0.0%)

Patient Outcomes

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

48,191 (99.5%)
Other 118 (0.2%)
Required Intervention 58 (0.1%)
Death 48 (0.1%)
Life Threatening 7 (0.0%)
R 6 (0.0%)
Hospitalization 4 (0.0%)
L 2 (0.0%)
O 2 (0.0%)
Disability 2 (0.0%)
D 1 (0.0%)
H 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

99
1999: 2
00
2000: 9
01
2001: 9
02
2002: 11
03
2003: 18
04
2004: 23
05
2005: 22
06
2006: 9
07
2007: 6
08
2008: 1
11
2011: 22
12
2012: 4
13
2013: 4
14
2014: 4
15
2015: 396
16
2016: 2,572
17
2017: 2,424
18
2018: 2,542
19
2019: 2,772
20
2020: 3,677
21
2021: 2,867
22
2022: 5,748
23
2023: 6,967
24
2024: 6,925
25
2025: 10,086
26
2026: 1,377