Device manufacturer, as written on reports

Invacare Florida Operations: medical device reports filed with FDA

48,884 reports name it as the manufacturer of the device involved, 2009–2016.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

48,884
reports naming it as manufacturer: 0.2% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

48,884 medical device reports received by FDA give Invacare Florida Operations as the manufacturer of the device involved, 0.2% of the MAUDE database, from January 2009 to December 2016. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (99.7%), injury (0.1%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Classified as death
Portable Oxygen Generator Concentrator Homefill	Generator, oxygen, portable	20,325	0.2%
Perfecto2 V With Sensor 9153650799	Generator, oxygen, portable	17,238	0%
Perfecto2 Oxygen Concentrator With Senso2 9153646963	Generator, oxygen, portable	4,832	0%
Platinum 10 Concen W/Sens O2 9153642105	Generator, oxygen, portable	1,551	0.6%
Ac-Powered Adjustable Hospital Bed Including Rails	Bed, ac-powered adjustable hospital	1,069	1.3%
Perfecto2 Oxygen Concentrator 9153646962	Generator, oxygen, portable	982	0.1%
Platinum 10 Concentrator 9153642104	Generator, oxygen, portable	313	0.9%
Semi Electric Foot Spring 9153638202	Bed, ac-powered adjustable hospital	307	0.3%
Xpo W/Supplemental Battery 9153648167	Generator, oxygen, portable	276	0.4%
Full Electric Foot Spring 9153638201	Bed, ac-powered adjustable hospital	227	0.4%
Bed Extender 9153650579	Bed, ac-powered adjustable hospital	209	0%
Cs Bed 9153650455	Bed, ac-powered adjustable hospital	178	0.2%
Xpo2 Portable Concentrator 9153648166	Generator, oxygen, portable	176	0%
Powered Patient Rotation Bed	Bed, patient rotation, powered	160	1.1%
Cs3 Bed 9153651161	Bed, ac-powered adjustable hospital	72	0%
Portable Air Compressor For Medical Purposes	Compressor, air, portable	36	0%
Powered Wheelchair	Wheelchair, powered	34	0.1%
Mechanical Manual Wheelchair	Wheelchair, mechanical	16	0%
Power Chair 20 Wide By 18 Deep For Pmi	Wheelchair, powered	7	0%
Daily Activity Assist Devices	Aid, transfer	4	0%
Non Ac-Powered Patient Lift	Lift, patient, non-ac-powered	2	0.3%
Mechanical Chair/Transport Chair	Chair, with casters	1	0.2%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
CAW	Generator, oxygen, portable	46,136	94.4%
FNL	Bed, ac-powered adjustable hospital	2,050	4.2%
OSI	Bariatric bed	332	0.7%
IKZ	Bed, patient rotation, powered	164	0.3%
ITI	Wheelchair, powered	57	0.1%
BTI	Compressor, air, portable	35	0.1%
IOR	Wheelchair, mechanical	29	0.1%
FNJ	Bed, manual	26	0.1%
LLI	Bed, therapeutic, ac-powered, adjustable home-use	10	0%
FNM	Mattress, air flotation, alternating pressure	7	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

Death0.1%41

Injury0.1%63

Malfunction99.7%48,744

Other0%3

Not given0.1%33

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Invacare Florida Operations reports

How many FDA device reports name Invacare Florida Operations as manufacturer?

48,884 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Portable Oxygen Generator Concentrator Homefill (20,325), Perfecto2 V With Sensor 9153650799 (17,238), Perfecto2 Oxygen Concentrator With Senso2 9153646963 (4,832), Platinum 10 Concen W/Sens O2 9153642105 (1,551) and Ac-Powered Adjustable Hospital Bed Including Rails (1,069).

Which device types does it report on?

generator, oxygen, portable (94.4%), bed, ac-powered adjustable hospital (4.2%), bariatric bed (0.7%) and bed, patient rotation, powered (0.3%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.