Reported Reactions

Devices › Generator, oxygen, portable

Device brand name · Generator oxygen portable

Xpo W/Supplemental Battery 9153648167: medical device reports filed with FDA

278 reports name it, 2014–2016. Manufacturer given most often on reports: Invacare Florida Operations. Product code CAW.

278
device reports naming the brand
0% of all MAUDE reports · about 24 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98.9%
classified as malfunction
96.3% across the product code
0.4%
classified as death, as reported
1 reports · not verified by FDA

278 medical device reports received by FDA name the brand "Xpo W/Supplemental Battery 9153648167" (generator oxygen portable); the manufacturer given most often on reports is Invacare Florida Operations; received from November 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 (98.9%), injury (0.7%) and death (0.4%); 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 break (36.3%), device alarm system (19.4%) and loss of power (18.7%). The patient problems coded most often are cyanosis, dyspnea and electric shock. 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 Xpo W/Supplemental Battery 9153648167 was received in the five years to August 2026; the latest was received in September 2016.

By year received

0711412014: 1420142015: 14120152016: 1232016

Event type and report source

Event type, as classified on the report

Death0.4%1
Injury0.7%2
Malfunction98.9%275
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%278
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Breakthe device broke10136.3%1.9%
Device alarm system5419.4%19%
Loss of powerthe device lost power5218.7%9.2%
Device operates differently than expectedthe device behaved unexpectedly4114.7%6.4%
Device displays incorrect message165.8%42.6%
No display/image114%0.1%
Failure to power up103.6%4.6%
Device inoperablethe device could not be used93.2%2.5%
Battery problema problem with the battery72.5%0.1%
Device stops intermittentlythe device stopped now and then41.4%2.2%
Gas output problem41.4%1.1%
Electrical /electronic property probleman electrical or electronic problem31.1%1.7%
Light interference31.1%0%
Charging problem20.7%0.1%
Device emits odor20.7%0.7%
Failure to charge20.7%0.1%
Failure to shut off20.7%0.1%
Material protrusion/extrusion20.7%0%
Mechanical problema mechanical problem20.7%1.8%
No audible alarm20.7%2.1%

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)ReportsShare
Cyanosis10.4%
Dyspneashortness of breath10.4%
Electric shockan electric shock10.4%
Respiratory distressdifficulty breathing10.4%
Underdoseless than the intended dose10.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureXpo W/Supplemental Battery 9153648167Product code CAWAll MAUDE reports
Reports27852,85226,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports4109
Classified as injury0.7%2.3%36.2%
Classified as malfunction98.9%96.3%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Portable Oxygen Generator Concentrator Homefill21,94500.2%
Perfecto2 V With Sensor 915365079917,70400%
Perfecto2 Oxygen Concentrator With Senso2 91536469635,12600%
Platinum 10 Concen W/Sens O2 91536421051,57800.6%
Perfecto2 Oxygen Concentrator 91536469621,49900.1%
Platinum 10 Concentrator 915364210434400.9%
Devilbiss43693.9%
Everflo Oxygen Concentrator260013.5%
EverFlo2371008.9%
Inogen One G5 Portable Oxygen Concentrator2011241.5%
SimplyGo190946.3%
Xpo2 Portable Concentrator 915364816617700%
SimplyGo Mini174355.2%
Portable Air Compressor For Medical Purposes2,70500%
Power Chair 20 Wide By 18 Deep For Pmi3,20200%

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 Xpo W/Supplemental Battery 9153648167 reports

How many FDA reports name Xpo W/Supplemental Battery 9153648167?

278 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 (98.9%), injury (0.7%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (36.3%), device alarm system (19.4%), loss of power (18.7%), device operates differently than expected (14.7%) and device displays incorrect message (5.8%). 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 Xpo W/Supplemental Battery 9153648167 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.