2026 data FDA MAUDE openFDA FDA Class II

Sv70 Ventilator

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §868.5895 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Sv70 Ventilator MID-BOOK · MAUDE

#75 of 1000 · 47,855 reports · 2000–2026

  • BOOK 47,855 reports
  • RANK #75 of 1000
  • DEATH 247 death-typed
  • INJ 517 injury-typed
  • MALF 47,041 malfunction
  • SPAN 2000–2026
  • PEAK 2019: 9,350
  • PHOTO Gas-Machine

Nearest event-volume peer: Gas-Machine, Anesthesia (90 report gap)

Sv70 Ventilator sits #75 of 1000 among tracked device types with 47,855 MAUDE reports spanning 2000–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Sv70 Ventilator carries 98.3% MALFUNCTION-coded reports, 33.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 1.1% corpus 30.3% · below corpus mean (-29.2 pp)
  • MALF 98.3% corpus 64.8% · above corpus mean (+33.5 pp)

Lead product-problem code Device Displays Incorrect Message is 12% of coded problems · Lead manufacturer RESPIRONICS CALIFORNIA, INC accounts for 48% of manufacturer-tagged reports · Top event location I is 50% of location-tagged rows .

Sv70 Ventilator in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Sv70 Ventilator carries 47,855 MAUDE reports, ranked #75 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 47,041 (98.3%)
Injury 517 (1.1%)
Death 247 (0.5%)
Other 37 (0.1%)
13 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

46,480 (98.0%)
Required Intervention 291 (0.6%)
Death 232 (0.5%)
Other 229 (0.5%)
Life Threatening 74 (0.2%)
Hospitalization 34 (0.1%)
R 30 (0.1%)
L 13 (0.0%)
O 9 (0.0%)
D 6 (0.0%)
Disability 6 (0.0%)
H 4 (0.0%)
S 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Device Displays Incorrect Message 4,415
Inadequate User Interface 4,318
Electrical /Electronic Property Problem 2,959
Device Alarm System 2,255
Defective Component 1,989
Device Operates Differently Than Expected 1,932
Battery Problem 1,776
Failure to Power Up 1,713
Device Sensing Problem 1,637
Circuit Failure 1,569
Incorrect, Inadequate or Imprecise Result or Readings 1,465
Therapeutic or Diagnostic Output Failure 1,451
Device Inoperable 1,405
No Display/Image 1,309
Defective Device 1,283
Unexpected Shutdown 1,081
Power Problem 1,021
Failure to Sense 954
Degraded 906
Output Problem 818

Yearly Trend

00
2000: 2
01
2001: 4
02
2002: 3
04
2004: 6
05
2005: 7
06
2006: 7
07
2007: 59
08
2008: 76
09
2009: 29
10
2010: 63
11
2011: 170
12
2012: 257
13
2013: 322
14
2014: 887
15
2015: 1,657
16
2016: 2,516
17
2017: 2,878
18
2018: 2,203
19
2019: 9,350
20
2020: 4,170
21
2021: 3,790
22
2022: 3,277
23
2023: 4,565
24
2024: 4,808
25
2025: 3,589
26
2026: 3,160

Reports in 2025 (3,589) held close to the prior two-year average of 4,687.

Related Entities for Sv70 Ventilator

Event Locations

I 23,871 (49.9%)
23,752 (49.6%)
HOSPITAL 143 (0.3%)
NO INFORMATION 72 (0.2%)
OTHER 12 (0.0%)
HOME 3 (0.0%)
INVALID DATA 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare RESPIRONICS CALIFORNIA, INC vs RESPIRONICS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sv70 Ventilator: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (47,855 here).

Similar death-typed counts

Nearest other device types by death-typed report count (247 here), distinct from the volume row.

Disclaimer: MAUDE figures for Sv70 Ventilator are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Sv70 Ventilator; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.