System, monitoring, perinatal: medical device reports filed with FDA

1,199 reports carry this product code, 1992–2026; 2 brands with a page.

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.

1,199
reports with this product code: 0% of all MAUDE reports; 126
reports, 12 months to August 2026: 156 in the 12 months before; 69%
classified as malfunction: 62.3% across all reports; 16.3%
classified as death, as reported: 0.9% across all reports

Product code HGM is FDA's classification for "System, monitoring, perinatal" (obstetrics/Gynecology panel), a class 2 device. 1,199 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

126 reports arrived in the 12 months to August 2026, down 19% from 156 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 (69%), death (16.3%) and injury (12%). 2 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Avalon Fm30 Fetal Monitor	210	3	21%	65.7%
Avalon FM20 Fetal Monitor	158	6	7.6%	86.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Philips Medizin Systeme B Blingen	543	45.3%
Philips Medical Systems	326	27.2%
Hill-Rom	37	3.1%
Ge Healthcare	27	2.3%
Philips Healthcare	3	0.3%
Philips Goldway Shenzhen Industrial	1	0.1%
Spacelabs Healthcare	1	0.1%

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 and report source

Event type

Death16.3%195

Injury12%144

Malfunction69%827

Other1.8%21

Not given1%12

Who filed

Manufacturer report87.2%1,045

Voluntary report3.8%45

User facility report0%0

Distributor report0.3%3

Not given8.8%106

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
No audible alarm	179	14.9%
No audible prompt/feedback	113	9.4%
Incorrect measurementthe device measured wrongly	100	8.3%
Device alarm system	90	7.5%
Insufficient device problem information	78	6.5%
Device operates differently than expectedthe device behaved unexpectedly	60	5%
Incorrect, inadequate or imprecise result or readings	51	4.3%
High readingsreadings were too high	40	3.3%
Defective alarm	38	3.2%
Display or visual feedback problem	34	2.8%
High test results	30	2.5%
Unable to obtain readings	22	1.8%
No display/image	19	1.6%
Material integrity problema problem with the device material	18	1.5%
Computer software problema software problem	17	1.4%
False reading from device non-compliance	17	1.4%
Defective devicethe device was defective	14	1.2%
Device issuea problem with the device	14	1.2%
Failure to analyze signal	14	1.2%
Imprecise or erratic results	14	1.2%

Questions about system, monitoring, perinatal reports

What is product code HGM?

FDA's classification code for "System, monitoring, perinatal", class 2, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,199 reports through August 2026, 126 of them in the latest 12 months.

Which brands appear most often?

Avalon Fm30 Fetal Monitor (210) and Avalon FM20 Fetal Monitor (158). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.