RESMED LTD

FDA MAUDE device safety record · 2007–2024

What the Data Shows About RESMED LTD

RESMED LTD is associated with 14,714 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2007 through 2024. Of the total, 126 are coded as death reports and 135 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 RESMED LTD 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 14,444 reports (98.2% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 2,603 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.

14,714
Total Reports
126
Death Reports
135
Injury Reports
20
Device Types

Event Types

Malfunction 14,444 (98.2%)
Injury 135 (0.9%)
Death 126 (0.9%)
Other 5 (0.0%)
4 (0.0%)

Patient Outcomes

14,511 (98.8%)
Death 126 (0.9%)
Other 21 (0.1%)
Required Intervention 8 (0.1%)
Hospitalization 6 (0.0%)
Life Threatening 4 (0.0%)
Disability 3 (0.0%)
H 1 (0.0%)
O 1 (0.0%)

Yearly Trend

07
2007: 2
09
2009: 2
10
2010: 6
11
2011: 14
12
2012: 8
13
2013: 3
14
2014: 47
15
2015: 698
16
2016: 1,385
17
2017: 1,831
18
2018: 1,776
19
2019: 766
20
2020: 2,603
21
2021: 2,560
22
2022: 1,732
23
2023: 1,279
24
2024: 2

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.