Generator, Oxygen, Portable
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 §868.5440 (Anesthesiology panel).
FDA MAUDE casebook
openFDA event book Generator, Oxygen, Portable MID-BOOK · MAUDE
#66 of 1000 · 52,785 reports · 1993–2026
- BOOK 52,785 reports
- RANK #66 of 1000
- DEATH 519 death-typed
- INJ 1,177 injury-typed
- MALF 50,878 malfunction
- SPAN 1993–2026
- PEAK 2014: 24,538
- PHOTO Syringe, Piston
Nearest event-volume peer: Syringe, Piston (26 report gap)
Generator, Oxygen, Portable sits #66 of 1000 among tracked device types with 52,785 MAUDE reports spanning 1993–2026. 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
Generator, Oxygen, Portable carries 96.4% MALFUNCTION-coded reports, 31.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
- INJ 2.2% corpus 30.3% · below corpus mean (-28.1 pp)
- MALF 96.4% corpus 64.8% · above corpus mean (+31.6 pp)
Lead product-problem code Device Displays Incorrect Message is 33% of coded problems · Lead manufacturer INVACARE FLORIDA OPERATIONS accounts for 97% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .
Generator, Oxygen, Portable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
52,959 reports
- Generator (this)
Generator, Oxygen, Portable
52,785 reports
- Syringe
Syringe, Piston
52,759 reports
- Drug Eluting…
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
52,206 reports
- Stimulator
Stimulator, Autonomic Nerve, Implanted For Epilepsy
51,898 reports
- Instrument
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
50,267 reports
What this shows Generator, Oxygen, Portable carries 52,785 MAUDE reports, ranked #66 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 616 in 2025, up from an average of 404 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Generator, Oxygen, Portable
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Generator, Oxygen, Portable: 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 (52,785 here).
Similar death-typed counts
Nearest other device types by death-typed report count (519 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Generator, Oxygen, Portable 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 Generator, Oxygen, Portable; 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.