Devices › Dc-defibrillator, low-energy, (including paddles)
Device brand name · Low energy defibrillator
Tempus LS-Manual: medical device reports filed with FDA
285 reports name it, 2022–2026. Manufacturer given most often on reports: Schiller. Product code LDD.
- 285
- device reports naming the brand
- 0% of all MAUDE reports · about 65 a year
- 8
- reports, 12 months to August 2026
- 31 in the 12 months before
- 76.5%
- classified as malfunction
- 89.2% across the product code
- 6.3%
- classified as death, as reported
- 18 reports · not verified by FDA
285 medical device reports received by FDA name the brand "Tempus LS-Manual" (low energy defibrillator); the manufacturer given most often on reports is Schiller; received from February 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
8 reports arrived in the 12 months to August 2026, down 74% from 31 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 (76.5%), injury (17.2%) and death (6.3%); 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 no pacing (49.1%), pacing problem (10.9%) and unable to obtain readings (9.1%). The patient problems coded most often are cardiac arrest, bradycardia and appropriate clinical signs, symptoms and conditions term/code not available. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| No pacing | 140 | 49.1% | 1.3% |
| Pacing problem | 31 | 10.9% | 6.6% |
| Unable to obtain readings | 26 | 9.1% | 0.6% |
| Loose or intermittent connection | 16 | 5.6% | 0.5% |
| Insufficient device problem information | 15 | 5.3% | 0.2% |
| Breakthe device broke | 9 | 3.2% | 0.5% |
| Failure to deliver shock/stimulation | 9 | 3.2% | 1.2% |
| Failure of device to self-test | 8 | 2.8% | 0.3% |
| Failure to charge | 7 | 2.5% | 8.6% |
| Mechanical problema mechanical problem | 7 | 2.5% | 0.3% |
| Display or visual feedback problem | 6 | 2.1% | 2.8% |
| Therapeutic or diagnostic output failure | 6 | 2.1% | 0% |
| Device handling problem | 5 | 1.8% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 1.4% | 0% |
| Defibrillation/stimulation problem | 4 | 1.4% | 3.3% |
| Device sensing problem | 4 | 1.4% | 0.3% |
| Electrical /electronic property probleman electrical or electronic problem | 4 | 1.4% | 0.5% |
| Failure to deliver energy | 4 | 1.4% | 5.8% |
| Fitting problem | 4 | 1.4% | 0.1% |
| Computer software problema software problem | 3 | 1.1% | 0.1% |
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 |
|---|---|---|
| Cardiac arrestthe heart stopped | 34 | 11.9% |
| Bradycardiaslow heart rate | 4 | 1.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 1.1% |
| Chest painchest pain | 2 | 0.7% |
| Asystole | 1 | 0.4% |
| Heart block | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
| Shock from patient lead(s) | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tempus LS-Manual | Product code LDD | All MAUDE reports |
|---|---|---|---|
| Reports | 285 | 16,581 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 63 | 57 | 9 |
| Classified as injury | 17.2% | 2.7% | 36.2% |
| Classified as malfunction | 76.5% | 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% |
| 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% |
| 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 Tempus LS-Manual reports
How many FDA reports name Tempus LS-Manual?
285 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
malfunction (76.5%), injury (17.2%) and death (6.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no pacing (49.1%), pacing problem (10.9%), unable to obtain readings (9.1%), loose or intermittent connection (5.6%) and insufficient device problem information (5.3%). 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 Tempus LS-Manual 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.