Devices › Ventilator, high frequency
Device brand name · Neonatal/pediatric ventilator
High Frequency Oscillatory Ventilator: medical device reports filed with FDA
636 reports name it, 1996–2015. Manufacturer given most often on reports: Sensormedics. Product code LSZ.
- 636
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 96.9%
- classified as malfunction
- 78.8% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 636 reports that name the brand "High Frequency Oscillatory Ventilator" (neonatal/pediatric ventilator), received between September 1996 and June 2015; the manufacturer given most often on reports is Sensormedics. 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 (96.9%), injury (1.1%) and other (1.1%); across all ventilator, high frequency reports (product code LSZ) death is recorded in 1.4% and malfunction in 78.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (41.5%), failure to cycle (10.4%) and noise (7.2%). The patient problems coded most often are manual ventilation required, therapy/non-surgical treatment, aborted/stopped and other (for use when an appropriate patient code cannot be identified). 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 High Frequency Oscillatory Ventilator was received in the five years to August 2026; the latest was received in June 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,099 reports carrying product code LSZ. 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 |
|---|---|---|---|
| Replace | 264 | 41.5% | 11.2% |
| Failure to cycle | 66 | 10.4% | 5.9% |
| Noise | 46 | 7.2% | 1.6% |
| Device issuea problem with the device | 44 | 6.9% | 2.2% |
| Other (for use when an appropriate device code cannot be identified) | 42 | 6.6% | 2.1% |
| Decrease in pressure | 38 | 6% | 3% |
| Loss of powerthe device lost power | 33 | 5.2% | 2.4% |
| Device emits odor | 27 | 4.2% | 1.2% |
| Pressure, insufficient | 23 | 3.6% | 1.1% |
| Overheating of device | 20 | 3.1% | 1.7% |
| Alarm, audible | 19 | 3% | 1.2% |
| Failure to calibrate | 18 | 2.8% | 0.8% |
| Repair | 15 | 2.4% | 0.9% |
| Failure to power up | 11 | 1.7% | 0.9% |
| Defective component | 9 | 1.4% | 0.8% |
| Device inoperablethe device could not be used | 8 | 1.3% | 3.1% |
| Difficult to position | 8 | 1.3% | 0.3% |
| Increase in pressure | 8 | 1.3% | 0.8% |
| Display or visual feedback problem | 7 | 1.1% | 0.7% |
| Erratic or intermittent display | 7 | 1.1% | 0.4% |
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 |
|---|---|---|
| Manual ventilation required | 44 | 6.9% |
| Therapy/non-surgical treatment, aborted/stopped | 42 | 6.6% |
| Other (for use when an appropriate patient code cannot be identified) | 13 | 2% |
| Therapy/non-surgical treatment, additional | 8 | 1.3% |
| Therapy/non-surgical treatment/delayed/prolonged | 7 | 1.1% |
| Low oxygen saturation | 5 | 0.8% |
| Deaththe patient died; cause not stated by this term | 4 | 0.6% |
| Airflow, restricted | 2 | 0.3% |
| Cardiopulmonary arrest | 2 | 0.3% |
| No patient involvement | 2 | 0.3% |
| Reintubate | 2 | 0.3% |
| Abnormal blood gases | 1 | 0.2% |
| Bleeding | 1 | 0.2% |
| Bradycardiaslow heart rate | 1 | 0.2% |
| Missed dose | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | High Frequency Oscillatory Ventilator | Product code LSZ | All MAUDE reports |
|---|---|---|---|
| Reports | 636 | 3,099 | 26,136,888 |
| Share of that pool | — | 20.5% | 0% |
| Classified as death, per 1,000 reports | 3 | 14 | 9 |
| Classified as injury | 1.1% | 18.1% | 36.2% |
| Classified as malfunction | 96.9% | 78.8% | 62.3% |
| Filed by the manufacturer | 99.8% | 93.2% | 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 LSZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 3100 High Frequency Oscillating Ventilator Hfov | 1,021 | 0 | 0.6% |
| Sensormedics | 288 | 0 | 6.6% |
| 3100 High Frequency Oscillatory Ventilator Hfov | 204 | 0 | 0.5% |
| Carefusion | 1,873 | 0 | 1.1% |
| Avea Ventilator | 3,943 | 0 | 0.5% |
| Viasys | 201 | 0 | 6% |
| Bird | 181 | 0 | 9.9% |
| Vela Ventilator | 8,446 | 0 | 0.3% |
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 High Frequency Oscillatory Ventilator reports
How many FDA reports name High Frequency Oscillatory Ventilator?
636 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 (96.9%), injury (1.1%) and other (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (41.5%), failure to cycle (10.4%), noise (7.2%), device issue (6.9%) and other (for use when an appropriate device code cannot be identified) (6.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that High Frequency Oscillatory Ventilator 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.