PHYSIO-CONTROL, INC. - 3015876

FDA MAUDE device safety record · 2009–2026

What the Data Shows About PHYSIO-CONTROL, INC. - 3015876

PHYSIO-CONTROL, INC. - 3015876 is associated with 20,880 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2026. Of the total, 239 are coded as death reports and 63 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 8 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for PHYSIO-CONTROL, INC. - 3015876 should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 20,578 reports (98.6% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 3,538 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.

20,880
Total Reports
239
Death Reports
63
Injury Reports
8
Device Types

Event Types

Malfunction 20,578 (98.6%)
Death 239 (1.1%)
Injury 63 (0.3%)

Patient Outcomes

20,392 (98.1%)
Death 304 (1.5%)
Other 46 (0.2%)
Required Intervention 20 (0.1%)
Life Threatening 7 (0.0%)
Hospitalization 6 (0.0%)
R 3 (0.0%)
D 2 (0.0%)
O 2 (0.0%)
Disability 2 (0.0%)

Yearly Trend

09
2009: 8
10
2010: 7
11
2011: 14
12
2012: 39
13
2013: 5
14
2014: 4
15
2015: 15
16
2016: 24
17
2017: 79
18
2018: 2,053
19
2019: 2,083
20
2020: 2,046
21
2021: 2,499
22
2022: 2,786
23
2023: 2,452
24
2024: 3,538
25
2025: 2,774
26
2026: 454

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.