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FDA product code CAW · class 2 · Anesthesiology
Generator, oxygen, portable: medical device reports filed with FDA
52,852 reports carry this product code, 1993–2026; 30 brands with a page.
- 52,852
- reports with this product code
- 0.2% of all MAUDE reports
- 680
- reports, 12 months to August 2026
- 511 in the 12 months before
- 96.3%
- classified as malfunction
- 62.3% across all reports
- 1%
- classified as death, as reported
- 0.9% across all reports
Product code CAW is FDA's classification for "Generator, oxygen, portable" (anesthesiology panel), a class 2 device. 52,852 medical device reports carry this product code, 0.2% of the MAUDE database, from October 1993 to August 2026.
680 reports arrived in the 12 months to August 2026, up 33% from 511 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 (96.3%), injury (2.3%) and death (1%). 30 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
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 |
|---|---|---|
| Invacare Florida Operations | 46,136 | 87.3% |
| Invacare Rehabilitation Equip | 1,573 | 3% |
| Respironics | 1,118 | 2.1% |
| Invacare Rehabilitation Equipment | 498 | 0.9% |
| Invacare Suzhou | 342 | 0.6% |
| Invacare | 281 | 0.5% |
| Invacare Taylor Street | 116 | 0.2% |
| Philips Respironics | 98 | 0.2% |
| Nellcor Puritan Bennett | 16 | 0% |
| Puritan Bennett | 16 | 0% |
| Puritan-Bennett | 15 | 0% |
| Invamex | 7 | 0% |
| Resmed | 7 | 0% |
| Philips / Respironics | 3 | 0% |
| Animas | 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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Device displays incorrect message | 22,495 | 42.6% |
| Device alarm system | 10,021 | 19% |
| Leak/splashthe device leaked | 5,539 | 10.5% |
| Loss of powerthe device lost power | 4,876 | 9.2% |
| Sticking | 4,331 | 8.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 3,386 | 6.4% |
| Failure to power up | 2,413 | 4.6% |
| Defective devicethe device was defective | 1,861 | 3.5% |
| Defective component | 1,408 | 2.7% |
| Device inoperablethe device could not be used | 1,324 | 2.5% |
| Electrical shorting | 1,274 | 2.4% |
| Device stops intermittentlythe device stopped now and then | 1,139 | 2.2% |
| Contamination | 1,112 | 2.1% |
| No audible alarm | 1,102 | 2.1% |
| Output below specifications | 1,092 | 2.1% |
| Positioning problem | 1,085 | 2.1% |
| Noise, audible | 1,046 | 2% |
| Breakthe device broke | 1,004 | 1.9% |
| Mechanical problema mechanical problem | 965 | 1.8% |
| Electrical /electronic property probleman electrical or electronic problem | 892 | 1.7% |
Questions about generator, oxygen, portable reports
What is product code CAW?
FDA's classification code for "Generator, oxygen, portable", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
52,852 reports through August 2026, 680 of them in the latest 12 months.
Which brands appear most often?
Portable Oxygen Generator Concentrator Homefill (21,904), Perfecto2 V With Sensor 9153650799 (17,696), Perfecto2 Oxygen Concentrator With Senso2 9153646963 (5,123), Platinum 10 Concen W/Sens O2 9153642105 (1,576) and Perfecto2 Oxygen Concentrator 9153646962 (1,497). 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.