Device brand name · Infusion pump
Signature Edition: medical device reports filed with FDA
220 reports name it, 1997–2002. Manufacturer given most often on reports: Alaris Medical Systems. Product code FRN.
- 220
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87.7%
- classified as malfunction
- 98.5% across the product code
- 1.8%
- classified as death, as reported
- 4 reports · not verified by FDA
220 medical device reports received by FDA name the brand "Signature Edition" (infusion pump); the manufacturer given most often on reports is Alaris Medical Systems; received from January 1997 to August 2002. 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 (87.7%), injury (10%) and death (1.8%); 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 malfunction (26.4%), device inoperable (25%) and excess flow or over-infusion (22.3%). The patient problems coded most often are overmedicated, overdose and therapy/non-surgical treatment, additional. 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 Signature Edition was received in the five years to August 2026; the latest was received in August 2002.
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 |
|---|---|---|---|
| Malfunction | 58 | 26.4% | 0% |
| Device inoperablethe device could not be used | 55 | 25% | 0.3% |
| Excess flow or over-infusion | 49 | 22.3% | 1.2% |
| Alarm, audible | 20 | 9.1% | 0.1% |
| Occlusion within devicethe device blocked | 16 | 7.3% | 0.6% |
| Air leak | 15 | 6.8% | 0.6% |
| Device alarm system | 13 | 5.9% | 2.8% |
| Other (for use when an appropriate device code cannot be identified) | 8 | 3.6% | 0.1% |
| Backflow | 6 | 2.7% | 0% |
| Out-of-box failure | 6 | 2.7% | 0% |
| Replace | 6 | 2.7% | 0.1% |
| Self-activation or keying | 6 | 2.7% | 0.1% |
| Inaccurate flow rate | 5 | 2.3% | 0.1% |
| Device issuea problem with the device | 4 | 1.8% | 0.1% |
| Increased pump speed | 4 | 1.8% | 0% |
| Program, failure to | 4 | 1.8% | 0% |
| Device displays incorrect message | 3 | 1.4% | 9.3% |
| Insufficient flow or under infusion | 3 | 1.4% | 0.8% |
| Loss of powerthe device lost power | 3 | 1.4% | 0.1% |
| Difficult or delayed activation | 2 | 0.9% | 0.1% |
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) | Reports | Share |
|---|---|---|
| Overmedicated | 26 | 11.8% |
| Overdosea dose above the recommended amount | 19 | 8.6% |
| Therapy/non-surgical treatment, additional | 8 | 3.6% |
| Infiltration into tissue | 6 | 2.7% |
| Other (for use when an appropriate patient code cannot be identified) | 4 | 1.8% |
| Therapy/non-surgical treatment/delayed/prolonged | 4 | 1.8% |
| Treatment with medication(s) | 4 | 1.8% |
| Blood pressure, decreased | 3 | 1.4% |
| Low blood pressure/ hypotension | 3 | 1.4% |
| Therapy/non-surgical treatment, aborted/stopped | 3 | 1.4% |
| Deaththe patient died; cause not stated by this term | 2 | 0.9% |
| Surgical procedure | 2 | 0.9% |
| Blood loss | 1 | 0.5% |
| Blood pressure, increased | 1 | 0.5% |
| Blood pressure, low | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Signature Edition | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 220 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 18 | 1 | 9 |
| Classified as injury | 10% | 1.3% | 36.2% |
| Classified as malfunction | 87.7% | 98.5% | 62.3% |
| Filed by the manufacturer | 98.6% | 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 Signature Edition reports
How many FDA reports name Signature Edition?
220 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 (87.7%), injury (10%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malfunction (26.4%), device inoperable (25%), excess flow or over-infusion (22.3%), alarm, audible (9.1%) and occlusion within device (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Signature Edition 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.