Devices › Generator, oxygen, portable
Device brand name · Generator oxygen portable
Perfecto2 Oxygen Concentrator With Senso2 9153646963: medical device reports filed with FDA
5,126 reports name it, 2014–2016. Manufacturer given most often on reports: Invacare Florida Operations. Product code CAW.
- 5,126
- device reports naming the brand
- 0% of all MAUDE reports · about 433 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.9%
- classified as malfunction
- 96.3% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
5,126 medical device reports received by FDA name the brand "Perfecto2 Oxygen Concentrator With Senso2 9153646963" (generator oxygen portable); the manufacturer given most often on reports is Invacare Florida Operations; received from September 2014 to September 2016. 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 (99.9%); across all generator, oxygen, portable reports (product code CAW) death is recorded in 1% and malfunction in 96.3%. 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 (46.8%), device alarm system (26.6%) and sticking (17.5%). The patient problems coded most often are low oxygen saturation, no patient involvement 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 Perfecto2 Oxygen Concentrator With Senso2 9153646963 was received in the five years to August 2026; the latest was received in September 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 52,852 reports carrying product code CAW. 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 | 2,400 | 46.8% | 42.6% |
| Device alarm system | 1,364 | 26.6% | 19% |
| Sticking | 898 | 17.5% | 8.2% |
| Leak/splashthe device leaked | 529 | 10.3% | 10.5% |
| Failure to power up | 325 | 6.3% | 4.6% |
| Loss of powerthe device lost power | 289 | 5.6% | 9.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 277 | 5.4% | 6.4% |
| No audible alarm | 230 | 4.5% | 2.1% |
| Defective devicethe device was defective | 205 | 4% | 3.5% |
| Electrical shorting | 195 | 3.8% | 2.4% |
| Electrical /electronic property probleman electrical or electronic problem | 143 | 2.8% | 1.7% |
| Defective component | 120 | 2.3% | 2.7% |
| Gas output problem | 113 | 2.2% | 1.1% |
| Output below specifications | 112 | 2.2% | 2.1% |
| Circuit failure | 111 | 2.2% | 1.5% |
| Device inoperablethe device could not be used | 110 | 2.1% | 2.5% |
| Positioning problem | 98 | 1.9% | 2.1% |
| Breakthe device broke | 83 | 1.6% | 1.9% |
| Mechanical problema mechanical problem | 77 | 1.5% | 1.8% |
| Noise, audible | 60 | 1.2% | 2% |
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 |
|---|---|---|
| Low oxygen saturation | 2 | 0% |
| No patient involvement | 2 | 0% |
| Deaththe patient died; cause not stated by this term | 1 | 0% |
| Drainage | 1 | 0% |
| Dyspneashortness of breath | 1 | 0% |
| Test result | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Perfecto2 Oxygen Concentrator With Senso2 9153646963 | Product code CAW | All MAUDE reports |
|---|---|---|---|
| Reports | 5,126 | 52,852 | 26,136,888 |
| Share of that pool | — | 9.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 10 | 9 |
| Classified as injury | 0% | 2.3% | 36.2% |
| Classified as malfunction | 99.9% | 96.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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 CAW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Portable Oxygen Generator Concentrator Homefill | 21,945 | 0 | 0.2% |
| Perfecto2 V With Sensor 9153650799 | 17,704 | 0 | 0% |
| Platinum 10 Concen W/Sens O2 9153642105 | 1,578 | 0 | 0.6% |
| Perfecto2 Oxygen Concentrator 9153646962 | 1,499 | 0 | 0.1% |
| Platinum 10 Concentrator 9153642104 | 344 | 0 | 0.9% |
| Devilbiss | 436 | 9 | 3.9% |
| Xpo W/Supplemental Battery 9153648167 | 278 | 0 | 0.4% |
| Everflo Oxygen Concentrator | 260 | 0 | 13.5% |
| EverFlo | 237 | 100 | 8.9% |
| Inogen One G5 Portable Oxygen Concentrator | 201 | 124 | 1.5% |
| SimplyGo | 190 | 94 | 6.3% |
| Xpo2 Portable Concentrator 9153648166 | 177 | 0 | 0% |
| SimplyGo Mini | 174 | 35 | 5.2% |
| Portable Air Compressor For Medical Purposes | 2,705 | 0 | 0% |
| Power Chair 20 Wide By 18 Deep For Pmi | 3,202 | 0 | 0% |
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 Perfecto2 Oxygen Concentrator With Senso2 9153646963 reports
How many FDA reports name Perfecto2 Oxygen Concentrator With Senso2 9153646963?
5,126 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 (99.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (46.8%), device alarm system (26.6%), sticking (17.5%), leak/splash (10.3%) and failure to power up (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Perfecto2 Oxygen Concentrator With Senso2 9153646963 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.