Devices › Outpatient cardiac telemetry
Device brand name · Detector and alarm arrhythmia
Zio AT: medical device reports filed with FDA
711 reports name it, 2022–2026. Manufacturer given most often on reports: Irhythm Technologies. Product code QYX.
- 711
- device reports naming the brand
- 0% of all MAUDE reports · about 186 a year
- 90
- reports, 12 months to August 2026
- 118 in the 12 months before
- 84.5%
- classified as malfunction
- 85.9% across the product code
- 3.5%
- classified as death, as reported
- 25 reports · not verified by FDA
FDA's MAUDE database holds 711 reports that name the brand "Zio AT" (detector and alarm arrhythmia), received between September 2022 and August 2026; the manufacturer given most often on reports is Irhythm Technologies. Spellings of one product vary from report to report.
90 reports arrived in the 12 months to August 2026, down 24% from 118 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 (84.5%), injury (12%) and death (3.5%); across all outpatient cardiac telemetry reports (product code QYX) death is recorded in 2% and malfunction in 85.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to transmit record (83%), patient-device incompatibility (8.9%) and inaccurate information (1.5%). The patient problems coded most often are skin inflammation/ irritation, hypersensitivity/allergic reaction and contact dermatitis. 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 640 reports carrying product code QYX. 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 |
|---|---|---|---|
| Failure to transmit record | 590 | 83% | 84.4% |
| Patient-device incompatibilitythe device did not suit the patient | 63 | 8.9% | 9.5% |
| Inaccurate information | 11 | 1.5% | 1.7% |
| Wireless communication problema wireless connection problem | 5 | 0.7% | 0.2% |
| Patient data problem | 4 | 0.6% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 0.4% | 0.2% |
| Human-device interface problem | 3 | 0.4% | 0% |
| Data problem | 2 | 0.3% | 0% |
| Device handling problem | 2 | 0.3% | 0% |
| Insufficient device problem information | 2 | 0.3% | 0.3% |
| Failure to sense | 1 | 0.1% | 0% |
| Incorrect interpretation of signal | 1 | 0.1% | 0% |
| Intermittent communication failure | 1 | 0.1% | 0% |
| Missing test results | 1 | 0.1% | 0% |
| Off-label use | 1 | 0.1% | 0% |
| Unclear information | 1 | 0.1% | 0.2% |
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 |
|---|---|---|
| Skin inflammation/ irritation | 39 | 5.5% |
| Hypersensitivity/allergic reaction | 15 | 2.1% |
| Contact dermatitis | 8 | 1.1% |
| Skin infection | 7 | 1% |
| Arrhythmia | 6 | 0.8% |
| Stroke/cva | 3 | 0.4% |
| Syncope/fainting | 3 | 0.4% |
| Anaphylactoid / anaphylaxis | 2 | 0.3% |
| Atrial fibrillationan irregular heart rhythm | 2 | 0.3% |
| Burn(s)a burn | 2 | 0.3% |
| Heart block | 2 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Cellulitisa skin infection | 1 | 0.1% |
| Fever | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zio AT | Product code QYX | All MAUDE reports |
|---|---|---|---|
| Reports | 711 | 640 | 26,136,888 |
| Share of that pool | — | 111.1% | 0% |
| Classified as death, per 1,000 reports | 35 | 20 | 9 |
| Classified as injury | 12% | 11.9% | 36.2% |
| Classified as malfunction | 84.5% | 85.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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."
Questions about Zio AT reports
How many FDA reports name Zio AT?
711 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 90 in the latest 12 months.
What kinds of events are reported?
malfunction (84.5%), injury (12%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to transmit record (83%), patient-device incompatibility (8.9%), inaccurate information (1.5%), wireless communication problem (0.7%) and patient data problem (0.6%). 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 Zio AT 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.