PHYSIO-CONTROL, INC

Manufacturer adverse-event records for PHYSIO-CONTROL, INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2007–2022 · mid-book · elevated Death-code · injury-light

Injury-mix signature

PHYSIO-CONTROL, INC is lighter on Injury codes

Injury-coded event_type share is 0.4% (injury-light tercile) beside 1.25% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for PHYSIO-CONTROL, INC

The standout signal for PHYSIO-CONTROL, INC is Injury-mix: 0.4% Injury-coded (injury-light) beside 1.25% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for PHYSIO-CONTROL, INC. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 8 device types, led in this extract by Malfunction at 9,192 (98.3% of event_type total). Peak single-year volume reaches 1,609 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,350
Total Reports
117
Event-type Death
39
Injury Reports
8
Device Types

Event Types

Malfunction 9,192 (98.3%)
Death 117 (1.3%)
Injury 39 (0.4%)
2 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

9,182 (98.0%)
Death 127 (1.4%)
Life Threatening 21 (0.2%)
R 19 (0.2%)
Required Intervention 13 (0.1%)
Other 4 (0.0%)
Hospitalization 2 (0.0%)
H 1 (0.0%)
L 1 (0.0%)
O 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

07
2007: 3
08
2008: 60
09
2009: 106
10
2010: 187
11
2011: 178
12
2012: 896
13
2013: 1,453
14
2014: 1,579
15
2015: 1,589
16
2016: 1,609
17
2017: 1,589
18
2018: 99
20
2020: 1
22
2022: 1