MAQUET CRITICAL CARE AB

FDA MAUDE device safety record · 2004–2026

What the Data Shows About MAQUET CRITICAL CARE AB

MAQUET CRITICAL CARE AB is associated with 20,392 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2026. Of the total, 174 are coded as death reports and 789 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MAQUET CRITICAL CARE AB should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 19,389 reports (95.1% of total). Patient-outcome categorizations are reported across 11 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 23 years of MAUDE data, with the peak single-year volume reaching 3,079 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

20,392
Total Reports
174
Death Reports
789
Injury Reports
20
Device Types

Event Types

Malfunction 19,389 (95.1%)
Injury 789 (3.9%)
Death 174 (0.9%)
31 (0.2%)
Other 9 (0.0%)

Patient Outcomes

19,370 (95.2%)
Life Threatening 710 (3.5%)
Death 169 (0.8%)
Required Intervention 37 (0.2%)
Other 31 (0.2%)
R 15 (0.1%)
Hospitalization 9 (0.0%)
L 8 (0.0%)
Disability 5 (0.0%)
D 2 (0.0%)
S 1 (0.0%)

Yearly Trend

04
2004: 95
05
2005: 101
06
2006: 119
07
2007: 274
08
2008: 277
09
2009: 294
10
2010: 295
11
2011: 260
12
2012: 162
13
2013: 442
14
2014: 623
15
2015: 524
16
2016: 576
17
2017: 653
18
2018: 709
19
2019: 957
20
2020: 1,380
21
2021: 3,079
22
2022: 2,412
23
2023: 2,635
24
2024: 2,227
25
2025: 1,979
26
2026: 319

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.