Device brand name · Ventilator continuous minimal ventilatory support facility use
V60 Ventilator: medical device reports filed with FDA
24,912 reports name it, 2009–2021. Manufacturer given most often on reports: Respironics California. Product code MNT.
- 24,912
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,473 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.8%
- classified as malfunction
- 98.3% across the product code
- 0.3%
- classified as death, as reported
- 72 reports · not verified by FDA
24,912 medical device reports received by FDA name the brand "V60 Ventilator" (ventilator continuous minimal ventilatory support facility use); the manufacturer given most often on reports is Respironics California; received from August 2009 to May 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (98.8%), injury (0.9%) and death (0.3%); across all sv70 ventilator reports (product code MNT) death is recorded in 0.5% and malfunction in 98.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (17.4%), defective component (7.9%) and device operates differently than expected (7.6%). The patient problems coded most often are no patient involvement, low oxygen saturation and death. 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 V60 Ventilator was received in the five years to August 2026; the latest was received in May 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 48,296 reports carrying product code MNT. 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 |
|---|---|---|---|
| Device displays incorrect message | 4,342 | 17.4% | 9.1% |
| Defective component | 1,967 | 7.9% | 4.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,883 | 7.6% | 4% |
| Therapeutic or diagnostic output failure | 1,433 | 5.8% | 3% |
| Incorrect, inadequate or imprecise result or readings | 1,430 | 5.7% | 3% |
| Device inoperablethe device could not be used | 1,364 | 5.5% | 2.9% |
| Defective devicethe device was defective | 1,278 | 5.1% | 2.7% |
| Failure to power up | 1,193 | 4.8% | 3.5% |
| Device alarm system | 1,134 | 4.6% | 4.7% |
| Battery problema problem with the battery | 1,051 | 4.2% | 3.7% |
| No display/image | 853 | 3.4% | 2.7% |
| Output problem | 785 | 3.2% | 1.7% |
| Loss of powerthe device lost power | 662 | 2.7% | 1.5% |
| Breakthe device broke | 432 | 1.7% | 1% |
| Inadequate user interface | 407 | 1.6% | 9% |
| Display or visual feedback problem | 403 | 1.6% | 1.3% |
| Temperature problem | 395 | 1.6% | 0.8% |
| Failure to charge | 345 | 1.4% | 1.2% |
| Power problem | 343 | 1.4% | 2.1% |
| Failure to calibrate | 337 | 1.4% | 0.8% |
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 |
|---|---|---|
| No patient involvement | 12,607 | 50.6% |
| Low oxygen saturation | 82 | 0.3% |
| Deaththe patient died; cause not stated by this term | 75 | 0.3% |
| Respiratory distressdifficulty breathing | 13 | 0.1% |
| Hypoxialow oxygen | 8 | 0% |
| Cardiopulmonary arrest | 7 | 0% |
| Bradycardiaslow heart rate | 6 | 0% |
| Dyspneashortness of breath | 4 | 0% |
| Injurya physical injury | 4 | 0% |
| Cardiac arrestthe heart stopped | 3 | 0% |
| Complaint, ill-defined | 3 | 0% |
| Abdominal distention | 2 | 0% |
| Bruise/contusion | 2 | 0% |
| Falla fall | 2 | 0% |
| Pulmonary emphysema | 2 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | V60 Ventilator | Product code MNT | All MAUDE reports |
|---|---|---|---|
| Reports | 24,912 | 48,296 | 26,136,888 |
| Share of that pool | — | 51.6% | 0.1% |
| Classified as death, per 1,000 reports | 3 | 5 | 9 |
| Classified as injury | 0.9% | 1.1% | 36.2% |
| Classified as malfunction | 98.8% | 98.3% | 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."
Other brands with product code MNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Respironics | 17,693 | 2,239 | 0.3% |
| BiPAP A40 | 2,979 | 1,775 | 1% |
| BiPAP A40 Pro | 1,050 | 344 | 0.5% |
| V60 V60Plus Ventilator | 363 | 117 | 0% |
| Bipap A40 System Silver | 242 | 0 | 0.8% |
| BiPAP A40 System Silver, JP | 179 | 141 | 0.6% |
| BiPAP A30 | 1,847 | 1,565 | 0.2% |
| BiPAP A30, Germany | 343 | 343 | 0% |
| Nihon Kohden NKV-550 Series Ventilator System | 277 | 64 | 0% |
| Ventilator | 174 | 3 | 7.5% |
| Ventilator Continuous Facility Use | 385 | 0 | 3.6% |
| ARCHITECT Syphilis TP | 153 | 22 | 0% |
| BiPAP A30-S, Germany | 178 | 178 | 0% |
| Breas Vivo 50 | 165 | 0 | 5.5% |
| DreamStation Auto CPAP | 146,780 | 27,741 | 0.9% |
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 V60 Ventilator reports
How many FDA reports name V60 Ventilator?
24,912 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 (98.8%), injury (0.9%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (17.4%), defective component (7.9%), device operates differently than expected (7.6%), therapeutic or diagnostic output failure (5.8%) and incorrect, inadequate or imprecise result or readings (5.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that V60 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.