BAXTER HEALTHCARE - MOUNTAIN HOME

FDA MAUDE device safety record · 2008–2020

What the Data Shows About BAXTER HEALTHCARE - MOUNTAIN HOME

BAXTER HEALTHCARE - MOUNTAIN HOME is associated with 52,989 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2020. Of the total, 392 are coded as death reports and 9,068 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 9 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BAXTER HEALTHCARE - MOUNTAIN HOME 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 43,464 reports (82.0% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 10,910 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.

52,989
Total Reports
392
Death Reports
9,068
Injury Reports
9
Device Types

Event Types

Malfunction 43,464 (82.0%)
Injury 9,068 (17.1%)
Death 392 (0.7%)
65 (0.1%)

Patient Outcomes

43,544 (76.5%)
Hospitalization 6,629 (11.7%)
R 3,510 (6.2%)
Required Intervention 1,384 (2.4%)
Other 1,014 (1.8%)
Death 405 (0.7%)
H 323 (0.6%)
O 63 (0.1%)
Congenital Anomaly 7 (0.0%)
Life Threatening 5 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

08
2008: 49
09
2009: 337
10
2010: 3,872
11
2011: 8,285
12
2012: 5,401
13
2013: 8,597
14
2014: 10,910
15
2015: 8,620
16
2016: 3,571
17
2017: 1,089
18
2018: 1,180
19
2019: 1,072
20
2020: 6

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.