What are FDA adverse event reports for System, Monitoring, Perinatal?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For System, Monitoring, Perinatal, there are 1,142 total reports including 194 death reports and 143 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for System, Monitoring, Perinatal?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

System, Monitoring, Perinatal

Name: System, Monitoring, Perinatal - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System, Monitoring, Perinatal LIGHT-BOOK · MAUDE

#621 of 1000 · 1,142 reports · 1992–2026

BOOK 1,142 reports
RANK #621 of 1000
DEATH 194 death-typed
INJ 143 injury-typed
MALF 780 malfunction
SPAN 1992–2026
PEAK 2024: 174
PHOTO Surgical Film

Nearest event-volume peer: Surgical Film (5 report gap)

System, Monitoring, Perinatal sits #621 of 1000 among tracked device types with 1,142 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 17.0% corpus 1.5% · above corpus mean (+15.5 pp)
INJ 12.5% corpus 30.4% · below corpus mean (-17.9 pp)
MALF 68.3% corpus 64.5% · above corpus mean (+3.8 pp)

Lead product-problem code No Audible Alarm is 19% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 91% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Agent

1,156
Filter

1,148
System (this)

1,142
Surgical Film

1,137
Bariatric Bed

1,133
Cardiovascula…

1,129

What this shows System, Monitoring, Perinatal carries 1,142 MAUDE reports, ranked #621 of 1000.

Event Types

Malfunction 780 (68.3%)

Death 194 (17.0%)

Injury 143 (12.5%)

Other 13 (1.1%)

12 (1.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

795 (68.5%)

Death 181 (15.6%)

Other 86 (7.4%)

Required Intervention 45 (3.9%)

Hospitalization 22 (1.9%)

Life Threatening 9 (0.8%)

O 8 (0.7%)

L 4 (0.3%)

R 4 (0.3%)

S 3 (0.3%)

Disability 3 (0.3%)

Yearly Trend

1992: 1

1996: 1

1997: 3

1998: 2

2000: 7

2001: 10

2002: 22

2003: 26

2004: 17

2005: 9

2006: 9

2007: 35

2008: 17

2009: 42

2010: 64

2011: 83

2012: 44

2013: 16

2014: 30

2015: 44

2016: 17

2017: 27

2018: 30

2019: 41

2020: 19

2021: 71

2022: 87

2023: 69

2024: 174

2025: 101

2026: 24

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 331

HILL-ROM INC. 16

HILL-ROM, INC. 15

Event Locations

832 (72.9%)

I 167 (14.6%)

HOSPITAL 120 (10.5%)

NO INFORMATION 19 (1.7%)

HOME 2 (0.2%)

OTHER 2 (0.2%)

Compare PHILIPS MEDICAL SYSTEMS vs HILL-ROM INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Monitoring, Perinatal, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,142 here).

Surgical Film 1,137 Filter, Infusion Line 1,148 Bariatric Bed 1,133 Cardiovascular Procedure Kit 1,129

Similar death-typed counts

Nearest other device types by death-typed report count (194 here), distinct from the volume row.

Electrode 194 Stimulator, Spinal-Cord, Implanted 196 Defibrillator, Implantable, Dual-Chamber 191 Implant, Intragastric For Morbid Obesity 191

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System, Monitoring, Perinatal are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Monitoring, Perinatal; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.

System, Monitoring, Perinatal

Event-type mix vs corpus