Device brand name · Infusion pump
Outlook Es: medical device reports filed with FDA
158 reports name it, 2010–2014. Manufacturer given most often on reports: B Braun Medical. Product code FRN.
- 158
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.4%
- classified as malfunction
- 98.5% across the product code
- 2.5%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 158 reports that name the brand "Outlook Es" (infusion pump), received between February 2010 and September 2014; the manufacturer given most often on reports is B Braun Medical. Spellings of one product vary from report to report.
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 (80.4%), injury (16.5%) and death (2.5%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (15.8%), device alarm system (14.6%) and infusion or flow problem (14.6%). The patient problems coded most often are overdose, death and underdose. 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 Outlook Es was received in the five years to August 2026; the latest was received in September 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,831,109 reports carrying product code FRN. 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 operates differently than expectedthe device behaved unexpectedly | 25 | 15.8% | 0.9% |
| Device alarm system | 23 | 14.6% | 2.8% |
| Infusion or flow problema problem with flow or infusion | 23 | 14.6% | 0.3% |
| Application interface becomes non-functional or program exits abnormally | 22 | 13.9% | 0% |
| Excess flow or over-infusion | 19 | 12% | 1.2% |
| Nonstandard device | 14 | 8.9% | 0.5% |
| Pumping stopped | 11 | 7% | 0.2% |
| Insufficient flow or under infusion | 10 | 6.3% | 0.8% |
| Display or visual feedback problem | 9 | 5.7% | 1.1% |
| Failure to shut off | 8 | 5.1% | 0% |
| Device displays incorrect message | 7 | 4.4% | 9.3% |
| Device inoperablethe device could not be used | 7 | 4.4% | 0.3% |
| Loss of powerthe device lost power | 5 | 3.2% | 0.1% |
| Programming issue | 4 | 2.5% | 0% |
| Device difficult to setup or prepare | 3 | 1.9% | 0% |
| Failure to pump | 3 | 1.9% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 2 | 1.3% | 0.8% |
| False alarm | 2 | 1.3% | 0.7% |
| Improper flow or infusion | 2 | 1.3% | 0.5% |
| Inaccurate delivery | 2 | 1.3% | 0.4% |
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 |
|---|---|---|
| Overdosea dose above the recommended amount | 8 | 5.1% |
| Deaththe patient died; cause not stated by this term | 4 | 2.5% |
| Underdoseless than the intended dose | 3 | 1.9% |
| Cardiac arrestthe heart stopped | 2 | 1.3% |
| Infiltration into tissue | 2 | 1.3% |
| Loss of consciousnesspassing out | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Outlook Es | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 158 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 25 | 1 | 9 |
| Classified as injury | 16.5% | 1.3% | 36.2% |
| Classified as malfunction | 80.4% | 98.5% | 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 FRN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris Pump Module | 684,522 | 0 | 0% |
| Alaris System | 422,501 | 33,692 | 0% |
| 8100 Alaris Pump Module | 163,620 | 0 | 0% |
| Spectrum Infusion Pump | 147,363 | 15 | 0% |
| 8015 Alaris System Pc Unit | 54,162 | 0 | 0% |
| Alaris System Pc Unit | 24,066 | 0 | 0% |
| 8110 Alaris Syringe Pump | 22,434 | 0 | 0% |
| Colleague | 21,763 | 0 | 0% |
| Reservoir 3ML MMT-332A | 19,914 | 2,008 | 0.4% |
| Reservoir 3ml | 16,407 | 0 | 0.8% |
| Flogard | 15,668 | 0 | 0% |
| Colleague Volumetric Infusion Pump | 13,678 | 0 | 0.1% |
| Colleague Pre P1 7 | 13,103 | 0 | 0% |
| CADD-Solis VIP Ambulatory Infusion Pump | 11,721 | 3,471 | 0.1% |
| Intermate | 8,261 | 47 | 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 Outlook Es reports
How many FDA reports name Outlook Es?
158 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 (80.4%), injury (16.5%) and death (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (15.8%), device alarm system (14.6%), infusion or flow problem (14.6%), application interface becomes non-functional or program exits abnormally (13.9%) and excess flow or over-infusion (12%). 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 Outlook Es 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.