Devices › System, monitoring, perinatal
Device brand name · Avalon fm20 fetal monitor
Avalon FM20 Fetal Monitor: medical device reports filed with FDA
158 reports name it, 2009–2026. Manufacturer given most often on reports: Philips Medizin Systeme B Blingen. Product code HGM.
- 158
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 6
- reports, 12 months to August 2026
- 31 in the 12 months before
- 86.1%
- classified as malfunction
- 69% across the product code
- 7.6%
- classified as death, as reported
- 12 reports · not verified by FDA
158 medical device reports received by FDA name the brand "Avalon FM20 Fetal Monitor" (avalon fm20 fetal monitor); the manufacturer given most often on reports is Philips Medizin Systeme B Blingen; received from June 2009 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, down 81% from 31 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 (86.1%), death (7.6%) and injury (5.7%); across all system, monitoring, perinatal reports (product code HGM) death is recorded in 16.3% and malfunction in 69%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no audible prompt/feedback (29.1%), no audible alarm (27.8%) and defective alarm (5.7%). 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,199 reports carrying product code HGM. 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 |
|---|---|---|---|
| No audible prompt/feedback | 46 | 29.1% | 9.4% |
| No audible alarm | 44 | 27.8% | 14.9% |
| Defective alarm | 9 | 5.7% | 3.2% |
| Unable to obtain readings | 9 | 5.7% | 1.8% |
| No visual prompts/feedback | 5 | 3.2% | 0.5% |
| Audible prompt/feedback problem | 3 | 1.9% | 0.5% |
| Incorrect measurementthe device measured wrongly | 3 | 1.9% | 8.3% |
| Device alarm system | 2 | 1.3% | 7.5% |
| High readingsreadings were too high | 2 | 1.3% | 3.3% |
| Image display error/artifact | 2 | 1.3% | 0.2% |
| Erratic or intermittent display | 1 | 0.6% | 0.5% |
| Failure to power up | 1 | 0.6% | 0.1% |
| False alarm | 1 | 0.6% | 0.2% |
| Imprecise or erratic results | 1 | 0.6% | 1.2% |
| Improper or incorrect procedure or method | 1 | 0.6% | 0.6% |
| Inaudible or unclear audible prompt/feedback | 1 | 0.6% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.6% | 4.3% |
| Insufficient device problem information | 1 | 0.6% | 6.5% |
| Low audible alarm | 1 | 0.6% | 0% |
| No device output | 1 | 0.6% | 0.8% |
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.
In context
| Measure | Avalon FM20 Fetal Monitor | Product code HGM | All MAUDE reports |
|---|---|---|---|
| Reports | 158 | 1,199 | 26,136,888 |
| Share of that pool | — | 13.2% | 0% |
| Classified as death, per 1,000 reports | 76 | 163 | 9 |
| Classified as injury | 5.7% | 12% | 36.2% |
| Classified as malfunction | 86.1% | 69% | 62.3% |
| Filed by the manufacturer | 100% | 87.2% | 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 HGM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Avalon Fm30 Fetal Monitor | 210 | 3 | 21% |
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 Avalon FM20 Fetal Monitor reports
How many FDA reports name Avalon FM20 Fetal Monitor?
158 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (86.1%), death (7.6%) and injury (5.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no audible prompt/feedback (29.1%), no audible alarm (27.8%), defective alarm (5.7%), unable to obtain readings (5.7%) and no visual prompts/feedback (3.2%). 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 Avalon FM20 Fetal Monitor 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.