Devices › Dc-defibrillator, low-energy, (including paddles)
Device brand name · External cardiac monitor
Lifepak 11 Diagnostic Cardiac Monitor: medical device reports filed with FDA
210 reports name it, 1996–2004. Manufacturer given most often on reports: Physio-Control. Product code LDD.
- 210
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.6%
- classified as malfunction
- 89.2% across the product code
- 2.4%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 210 reports that name the brand "Lifepak 11 Diagnostic Cardiac Monitor" (external cardiac monitor), received between October 1996 and July 2004; the manufacturer given most often on reports is Physio-Control. Spellings of one product vary from report to report.
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 (97.6%) and death (2.4%); 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 signal artifact/noise (23.8%), display or visual feedback problem (20.5%) and no display/image (10%). 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 Diagnostic Cardiac Monitor was received in the five years to August 2026; the latest was received in July 2004.
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 |
|---|---|---|---|
| Signal artifact/noise | 50 | 23.8% | 1.5% |
| Display or visual feedback problem | 43 | 20.5% | 2.8% |
| No display/image | 21 | 10% | 6.3% |
| Pacing problem | 13 | 6.2% | 6.6% |
| Replace | 12 | 5.7% | 11.5% |
| Ekg/ECG analysis, failure to perform | 7 | 3.3% | 1% |
| Failure, intermittent | 7 | 3.3% | 2.6% |
| Loss of powerthe device lost power | 7 | 3.3% | 4.8% |
| Failure to power up | 5 | 2.4% | 8.3% |
| Interference with pacemaker | 5 | 2.4% | 0% |
| Failure to capture | 4 | 1.9% | 0.6% |
| Blank screen | 3 | 1.4% | 1.8% |
| Inaccurate synchronization | 3 | 1.4% | 0.3% |
| Repair | 3 | 1.4% | 1% |
| Battery failure | 2 | 1% | 1.1% |
| Failure to cycle | 2 | 1% | 0% |
| Monitor failure | 2 | 1% | 0.4% |
| Alarm, audible | 1 | 0.5% | 0.4% |
| Device inoperablethe device could not be used | 1 | 0.5% | 5.5% |
| Erratic or intermittent display | 1 | 0.5% | 0.9% |
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 | 15 | 7.1% |
| Resuscitation | 5 | 2.4% |
| Asystole | 1 | 0.5% |
| Chest painchest pain | 1 | 0.5% |
| Device induced | 1 | 0.5% |
| Hospitalization required | 1 | 0.5% |
| Misdiagnosis | 1 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lifepak 11 Diagnostic Cardiac Monitor | Product code LDD | All MAUDE reports |
|---|---|---|---|
| Reports | 210 | 16,581 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 24 | 57 | 9 |
| Classified as injury | 0% | 2.7% | 36.2% |
| Classified as malfunction | 97.6% | 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% |
| Codemaster 100 | 198 | 0 | 5.1% |
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 Diagnostic Cardiac Monitor reports
How many FDA reports name Lifepak 11 Diagnostic Cardiac Monitor?
210 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 (97.6%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
signal artifact/noise (23.8%), display or visual feedback problem (20.5%), no display/image (10%), pacing problem (6.2%) and replace (5.7%). 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 Diagnostic Cardiac Monitor 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.