MAQUET CV

FDA MAUDE device safety record · 2015–2019

What the Data Shows About MAQUET CV

MAQUET CV is associated with 4,465 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2019. Of the total, 3 are coded as death reports and 229 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 13 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MAQUET CV should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 4,231 reports (94.8% of total). Patient-outcome categorizations are reported across 5 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 5 years of MAUDE data, with the peak single-year volume reaching 1,308 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.

4,465
Total Reports
3
Death Reports
229
Injury Reports
13
Device Types

Event Types

Malfunction 4,231 (94.8%)
Injury 229 (5.1%)
Death 3 (0.1%)
2 (0.0%)

Patient Outcomes

4,209 (93.9%)
Other 185 (4.1%)
Required Intervention 69 (1.5%)
R 18 (0.4%)
Death 2 (0.0%)

Yearly Trend

15
2015: 424
16
2016: 1,303
17
2017: 1,133
18
2018: 1,308
19
2019: 297

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.