Devices › Dc-defibrillator, low-energy, (including paddles)
Device brand name · External dc defibrillator/transcutaneous pacer
Lifepak 11 Defibrillator/Pacemaker: medical device reports filed with FDA
181 reports name it, 1996–2008. Manufacturer given most often on reports: Physio-Control. Product code LDD.
- 181
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 86.7%
- classified as malfunction
- 89.2% across the product code
- 12.7%
- classified as death, as reported
- 23 reports · not verified by FDA
181 medical device reports received by FDA name the brand "Lifepak 11 Defibrillator/Pacemaker" (external dc defibrillator/transcutaneous pacer); the manufacturer given most often on reports is Physio-Control; received from October 1996 to September 2008. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (86.7%), death (12.7%) and injury (0.6%); across all dc-defibrillator, low-energy, (including paddles) reports (product code LDD) death is recorded in 5.7% and malfunction in 89.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are pacing problem (34.8%), display or visual feedback problem (8.3%) and replace (8.3%). The patient problems coded most often are death, resuscitation and asystole. 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."
Reports by month, five years
No report naming Lifepak 11 Defibrillator/Pacemaker was received in the five years to August 2026; the latest was received in September 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 16,581 reports carrying product code LDD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Pacing problem | 63 | 34.8% | 6.6% |
| Display or visual feedback problem | 15 | 8.3% | 2.8% |
| Replace | 15 | 8.3% | 11.5% |
| Failure to deliver energy | 13 | 7.2% | 5.8% |
| Signal artifact/noise | 10 | 5.5% | 1.5% |
| No display/image | 8 | 4.4% | 6.3% |
| Failure to deliver shock/stimulation | 7 | 3.9% | 1.2% |
| Failure, intermittent | 7 | 3.9% | 2.6% |
| Defibrillation/stimulation problem | 6 | 3.3% | 3.3% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 3.3% | 3% |
| Pacing intermittently | 6 | 3.3% | 0.3% |
| Failure to charge | 5 | 2.8% | 8.6% |
| Arcing at paddles | 4 | 2.2% | 0.3% |
| Arcing of electrodes | 4 | 2.2% | 0.2% |
| Failure to discharge | 4 | 2.2% | 7.7% |
| Self-activation or keying | 3 | 1.7% | 0.8% |
| Battery failure | 2 | 1.1% | 1.1% |
| Device displays incorrect message | 2 | 1.1% | 12.3% |
| Device inoperablethe device could not be used | 2 | 1.1% | 5.5% |
| Ekg/ECG analysis, failure to perform | 2 | 1.1% | 1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 33 | 18.2% |
| Resuscitation | 9 | 5% |
| Asystole | 7 | 3.9% |
| Therapy/non-surgical treatment/delayed/prolonged | 3 | 1.7% |
| Burn(s)a burn | 1 | 0.6% |
| Hospitalization required | 1 | 0.6% |
| Idioventricular rhythm | 1 | 0.6% |
| Improved patient condition | 1 | 0.6% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.6% |
| Treatment with medication(s) | 1 | 0.6% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lifepak 11 Defibrillator/Pacemaker | Product code LDD | All MAUDE reports |
|---|---|---|---|
| Reports | 181 | 16,581 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 127 | 57 | 9 |
| Classified as injury | 0.6% | 2.7% | 36.2% |
| Classified as malfunction | 86.7% | 89.2% | 62.3% |
| Filed by the manufacturer | 100% | 92.7% | 94.9% |
Shares are of reports, not 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."
Other brands with product code LDD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Lifepak 20 Defibrillator/Monitor | 2,753 | 1 | 0.8% |
| Lifepak 12 Defibrillator/Monitor Series | 3,608 | 0 | 4.9% |
| Pd1400 Defibrillator/Pacemaker | 1,777 | 0 | 6.1% |
| Pd1200 Defibrillator/Pacemaker | 1,380 | 0 | 4.9% |
| Lifepak R 20 Defibrillator/Monitor | 2,248 | 4 | 0.5% |
| Lifepak 10 Defibrillator/Monitor/Pacemaker | 622 | 0 | 4.7% |
| Lifepak 9p Defibrillator/Monitor/Pacemaker | 628 | 0 | 2.9% |
| Codemaster Xl | 427 | 0 | 2.1% |
| Autoclavable Internal Handles Mseries | 379 | 1 | 0.5% |
| Tempus LS-Manual | 285 | 8 | 6.3% |
| Lifepak 9 Defibrillator/Monitor | 264 | 0 | 5.7% |
| Heartstart Mrx | 18,592 | 0 | 0.7% |
| Codemaster Xl+ | 251 | 0 | 2.8% |
| D900 Defibrillator | 215 | 0 | 3.3% |
| Lifepak 11 Diagnostic Cardiac Monitor | 210 | 0 | 2.4% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Lifepak 11 Defibrillator/Pacemaker reports
How many FDA reports name Lifepak 11 Defibrillator/Pacemaker?
181 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (86.7%), death (12.7%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pacing problem (34.8%), display or visual feedback problem (8.3%), replace (8.3%), failure to deliver energy (7.2%) and signal artifact/noise (5.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lifepak 11 Defibrillator/Pacemaker was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.