Device manufacturer, as written on reports
Physio-Control: medical device reports filed with FDA
17,268 reports name it as the manufacturer of the device involved, 1992–2026.
- 17,268
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 28
- reports, 12 months to August 2026
- 61 in the 12 months before
- 96.3%
- classified as malfunction
- 62.3% across all reports
- 2.3%
- classified as death, as reported
- 0.9% across all reports
17,268 medical device reports received by FDA give Physio-Control as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1992 to July 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
28 reports arrived in the 12 months to August 2026, down 54% from 61 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.3%), death (2.3%) and injury (1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Lifepak 20 Defibrillator/Monitor | Dc-defibrillator, low-energy, (including paddles) | 2,128 | 1 | 0.8% |
| Lifepak R 15 Monitor/Defibrillator | Automated external defibrillators (non-wearable) | 1,966 | 463 | 1.4% |
| Lifepak R 20 Defibrillator/Monitor | Automated external defibrillators (non-wearable) | 1,760 | 4 | 0.5% |
| Lifepak Cr R Plus Defibrillator | Automated external defibrillators (non-wearable) | 1,677 | 12 | 0.6% |
| Lifepak 12 Defibrillator/Monitor Series | Dc-defibrillator, low-energy, (including paddles) | 1,527 | 0 | 4.9% |
| Lifepak R 12 Defibrillator/Monitor Series | Automated external defibrillators (non-wearable) | 1,423 | 0 | 1.5% |
| Lifepak Cr Plus Defibrillator | Automated external defibrillators (non-wearable) | 928 | 12 | 0.9% |
| Lifepak R 1000 Defibrillator | Automated external defibrillators (non-wearable) | 715 | 30 | 3.3% |
| Lifepak R 20e Defibrillator/Monitor | Automated external defibrillators (non-wearable) | 670 | 54 | 1.2% |
| Lifepak 9p Defibrillator/Monitor/Pacemaker | Dc-defibrillator, low-energy, (including paddles) | 361 | 0 | 2.9% |
| Lifepak 500 Automated External Defibrillator | Automated external defibrillators (non-wearable) | 359 | 0 | 10% |
| Lifepak 10 Defibrillator/Monitor/Pacemaker | Dc-defibrillator, low-energy, (including paddles) | 346 | 0 | 4.7% |
| Biphasic Lifepak 500 Automated External Defibrillator | Automated external defibrillators (non-wearable) | 242 | 0 | 6.2% |
| LIFEPAK 15 monitor/defibrillator | Automated external defibrillators (non-wearable) | 218 | 154 | 1.1% |
| Biphasic Lifepak R 500 Automated External Defibrillator | Automated external defibrillators (non-wearable) | 217 | 0 | 2.9% |
| Lifepak 9 Defibrillator/Monitor | Dc-defibrillator, low-energy, (including paddles) | 194 | 0 | 5.7% |
| LIFEPAK 1000 defibrillator | Automated external defibrillators (non-wearable) | 157 | 36 | 3.2% |
| Lifepak 11 Diagnostic Cardiac Monitor | Dc-defibrillator, low-energy, (including paddles) | 156 | 0 | 2.4% |
| Lifepak 11 Defibrillator/Pacemaker | Dc-defibrillator, low-energy, (including paddles) | 120 | 0 | 12.7% |
| LIFEPAK 20e defibrillator/monitor | Automated external defibrillators (non-wearable) | 116 | 91 | 1% |
| Lifepak 300 Automatic Advisory Defibrillator | Automated external defibrillators (non-wearable) | 100 | 0 | 13.2% |
| LIFEPAK 15 defibrillator/monitor | Automated external defibrillators (non-wearable) | 10 | 369 | 1% |
| Lucas 3 Chest Compression System | Compressor, cardiac, external | 1 | 185 | 5.1% |
Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| MKJ | Automated external defibrillators (non-wearable) | 11,975 | 69.3% |
| LDD | Dc-defibrillator, low-energy, (including paddles) | 5,044 | 29.2% |
| MLN | Electrode, electrocardiograph, multi-function | 102 | 0.6% |
| DRM | Compressor, cardiac, external | 24 | 0.1% |
| DRO | Pacemaker, cardiac, external transcutaneous (non-invasive) | 22 | 0.1% |
| IKD | Cable, electrode | 5 | 0% |
| DRT | Monitor, cardiac (incl. cardiotachometer & rate alarm) | 4 | 0% |
| DSA | Cable, transducer and electrode, patient, (including connector) | 3 | 0% |
| DTE | Pulse-generator, pacemaker, external | 3 | 0% |
| LDF | Electrode, pacemaker, temporary | 3 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Physio-Control reports
How many FDA device reports name Physio-Control as manufacturer?
17,268 reports through August 2026, 28 of them in the latest 12 months.
Which of its brands appear most often?
Lifepak 20 Defibrillator/Monitor (2,128), Lifepak R 15 Monitor/Defibrillator (1,966), Lifepak R 20 Defibrillator/Monitor (1,760), Lifepak Cr R Plus Defibrillator (1,677) and Lifepak 12 Defibrillator/Monitor Series (1,527).
Which device types does it report on?
automated external defibrillators (non-wearable) (69.3%), dc-defibrillator, low-energy, (including paddles) (29.2%), electrode, electrocardiograph, multi-function (0.6%) and compressor, cardiac, external (0.1%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.