Sv70 ventilator: medical device reports filed with FDA

48,296 reports carry this product code, 2000–2026; 18 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

48,296
reports with this product code: 0.2% of all MAUDE reports; 4,886
reports, 12 months to August 2026: 4,526 in the 12 months before; 98.3%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code MNT is FDA's classification for "Sv70 ventilator" (anesthesiology panel), a class 2 device. 48,296 medical device reports carry this product code, 0.2% of the MAUDE database, from October 2000 to August 2026.

4,886 reports arrived in the 12 months to August 2026, close to the 4,526 of 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 (98.3%), injury (1.1%) and death (0.5%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
V60 Ventilator	24,900	0	0.3%	98.8%
Respironics	17,316	2,239	0.3%	98.7%
BiPAP A40	2,939	1,775	1%	98.4%
BiPAP A40 Pro	1,043	344	0.5%	99.3%
V60 V60Plus Ventilator	363	117	0%	99.7%
Bipap A40 System Silver	220	0	0.8%	97.9%
BiPAP A40 System Silver, JP	179	141	0.6%	97.8%
BiPAP A30	48	1,565	0.2%	99.5%
BiPAP A30, Germany	5	343	0%	100%
Nihon Kohden NKV-550 Series Ventilator System	5	64	0%	99.3%
Ventilator	2	3	7.5%	33.3%
Ventilator Continuous Facility Use	2	0	3.6%	91.9%
ARCHITECT Syphilis TP	1	22	0%	90.2%
BiPAP A30-S, Germany	1	178	0%	100%
Breas Vivo 50	1	0	5.5%	92.1%
DreamStation Auto CPAP	1	27,741	0.9%	86.4%
Esprit Ventilator	1	0	0.4%	98.2%
Philips	1	0	6.3%	78.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Respironics California	27,841	57.6%
Respironics	16,554	34.3%
Fisher & Paykel Healthcare	241	0.5%
Resmed	79	0.2%
Maquet Critical Care	49	0.1%
Philips Respironics	31	0.1%
Nellcor Puritan Bennett	15	0%
Philips Medical Systems	12	0%
Philips North America	3	0%
Philips Healthcare	2	0%
Philips / Respironics	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.5%248

Injury1.1%521

Malfunction98.3%47,477

Other0.1%37

Not given0%13

Who filed

Manufacturer report99.5%48,041

Voluntary report0.1%66

User facility report0%0

Distributor report0.1%31

Not given0.3%158

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	4,415	9.1%
Inadequate user interface	4,327	9%
Electrical /electronic property probleman electrical or electronic problem	3,205	6.6%
Device alarm system	2,268	4.7%
Defective component	1,989	4.1%
Device operates differently than expectedthe device behaved unexpectedly	1,932	4%
Circuit failure	1,798	3.7%
Battery problema problem with the battery	1,775	3.7%
Failure to power up	1,714	3.5%
Device sensing problem	1,644	3.4%
Incorrect, inadequate or imprecise result or readings	1,466	3%
Therapeutic or diagnostic output failure	1,448	3%
Device inoperablethe device could not be used	1,404	2.9%
No display/image	1,318	2.7%
Defective devicethe device was defective	1,282	2.7%
Unexpected shutdown	1,091	2.3%
Power problem	1,019	2.1%
Failure to sense	968	2%
Degraded	937	1.9%
Output problem	814	1.7%

Questions about sv70 ventilator reports

What is product code MNT?

FDA's classification code for "Sv70 ventilator", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

48,296 reports through August 2026, 4,886 of them in the latest 12 months.

Which brands appear most often?

V60 Ventilator (24,900), Respironics (17,316), BiPAP A40 (2,939), BiPAP A40 Pro (1,043) and V60 V60Plus Ventilator (363). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.