Devices › Automated external defibrillators (non-wearable)
Device brand name · Electrode
Onestep: medical device reports filed with FDA
167 reports name it, 2014–2026. Manufacturer given most often on reports: Bio-Detek. Product code MKJ.
- 167
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 47
- reports, 12 months to August 2026
- 69 in the 12 months before
- 86.8%
- classified as malfunction
- 96.8% across the product code
- 1.8%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 167 reports that name the brand "Onestep" (electrode), received between September 2014 and August 2026; the manufacturer given most often on reports is Bio-Detek. Spellings of one product vary from report to report.
47 reports arrived in the 12 months to August 2026, down 32% from 69 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 (86.8%), injury (10.8%) and death (1.8%); across all automated external defibrillators (non-wearable) reports (product code MKJ) death is recorded in 1.7% and malfunction in 96.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unable to obtain readings (19.8%), failure of device to self-test (16.8%) and patient device interaction problem (15.6%). The patient problems coded most often are burn(s), cardiac arrest and skin tears. 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 269,686 reports carrying product code MKJ. 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 |
|---|---|---|---|
| Unable to obtain readings | 33 | 19.8% | 4.4% |
| Failure of device to self-test | 28 | 16.8% | 8.9% |
| Patient device interaction problem | 26 | 15.6% | 0.1% |
| Failure to deliver shock/stimulation | 7 | 4.2% | 1.8% |
| Material separation | 6 | 3.6% | 0.1% |
| Pacing problem | 4 | 2.4% | 1.2% |
| Sparking | 4 | 2.4% | 0.2% |
| Detachment of device or device componentpart of the device came off | 3 | 1.8% | 1.8% |
| Arcing of electrodes | 2 | 1.2% | 0% |
| Connection problema connection problem | 2 | 1.2% | 0.5% |
| Fracturea broken bone | 2 | 1.2% | 0.1% |
| Packaging problem | 2 | 1.2% | 0% |
| Accessory incompatible | 1 | 0.6% | 0.1% |
| Adhesive too strong | 1 | 0.6% | 0% |
| Breakthe device broke | 1 | 0.6% | 1.4% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.6% | 0.2% |
| Defective devicethe device was defective | 1 | 0.6% | 1.2% |
| Device alarm system | 1 | 0.6% | 0.2% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 0% |
| Difficult to open or remove packaging material | 1 | 0.6% | 0% |
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 |
|---|---|---|
| Burn(s)a burn | 9 | 5.4% |
| Cardiac arrestthe heart stopped | 5 | 3% |
| Skin tears | 4 | 2.4% |
| Superficial (first degree) burn | 3 | 1.8% |
| Asystole | 2 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.2% |
| Airway obstruction | 1 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.6% |
| Arrhythmia | 1 | 0.6% |
| Bradycardiaslow heart rate | 1 | 0.6% |
| Heart block | 1 | 0.6% |
| Intraoperative cardiac valve injury | 1 | 0.6% |
| Low oxygen saturation | 1 | 0.6% |
| Respiratory arrestbreathing stopped | 1 | 0.6% |
| Subcutaneous nodule | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Onestep | Product code MKJ | All MAUDE reports |
|---|---|---|---|
| Reports | 167 | 269,686 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 18 | 17 | 9 |
| Classified as injury | 10.8% | 0.7% | 36.2% |
| Classified as malfunction | 86.8% | 96.8% | 62.3% |
| Filed by the manufacturer | 73.1% | 99.3% | 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 MKJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| M Series | 27,112 | 4 | 2.3% |
| Heartstart Mrx | 18,592 | 0 | 0.7% |
| HeartStart MRx -EMS Defibrillator | 16,166 | 33 | 0.8% |
| Heart Start XL | 15,944 | 95 | 0.9% |
| R Series Defibrillator | 15,393 | 0 | 0.9% |
| X Series | 13,983 | 1,692 | 2.7% |
| HeartStart XL+ Defibrillator/Monitor | 13,188 | 210 | 0.4% |
| Heartstart Onsite | 10,964 | 0 | 0.8% |
| Aed Plus | 9,225 | 423 | 2.2% |
| Heartsine Samaritan 300p And Pad Pak | 8,197 | 0 | 0.3% |
| E Series Defibrillator | 8,052 | 0 | 1.5% |
| Lifepak R 15 Monitor/Defibrillator | 6,117 | 463 | 1.4% |
| Heartstart Frx | 5,978 | 2 | 1.3% |
| Efficia Dfm100 | 5,076 | 0 | 0.6% |
| LIFEPAK 15 defibrillator/monitor | 4,716 | 369 | 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 Onestep reports
How many FDA reports name Onestep?
167 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 47 in the latest 12 months.
What kinds of events are reported?
malfunction (86.8%), injury (10.8%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unable to obtain readings (19.8%), failure of device to self-test (16.8%), patient device interaction problem (15.6%), failure to deliver shock/stimulation (4.2%) and material separation (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (73.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Onestep 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.