What are FDA adverse event reports for Monitor, Apnea, Facility Use?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Monitor, Apnea, Facility Use, there are 620 total reports including 82 death reports and 21 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 Monitor, Apnea, Facility Use?

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.

2019 data FDA MAUDE openFDA

Monitor, Apnea, Facility Use

Name: Monitor, Apnea, Facility Use - 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 Monitor, Apnea, Facility Use LIGHT-BOOK · MAUDE

#800 of 1000 · 620 reports · 1992–2019

BOOK 620 reports
RANK #800 of 1000
DEATH 82 death-typed
INJ 21 injury-typed
MALF 494 malfunction
SPAN 1992–2019
PEAK 1997: 96
PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management (0 report gap)

Monitor, Apnea, Facility Use sits #800 of 1000 among tracked device types with 620 MAUDE reports spanning 1992–2019. 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 13.2% corpus 1.5% · above corpus mean (+11.7 pp)
INJ 3.4% corpus 30.4% · below corpus mean (-27.1 pp)
MALF 79.7% corpus 64.5% · above corpus mean (+15.2 pp)

Lead product-problem code Device Alarm System is 36% of coded problems · Lead manufacturer RESPIRONICS, INC. accounts for 60% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Bit, Surgical

622
Accessories

621
Monitor (this)

620
Integrated Co…

620
System

616
Nebulizer

615

What this shows Monitor, Apnea, Facility Use carries 620 MAUDE reports, ranked #800 of 1000.

Event Types

Malfunction 494 (79.7%)

Death 82 (13.2%)

Injury 21 (3.4%)

Other 19 (3.1%)

4 (0.6%)

Patient Outcomes

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

Other 291 (46.0%)

214 (33.8%)

Death 79 (12.5%)

Hospitalization 27 (4.3%)

Required Intervention 6 (0.9%)

O 5 (0.8%)

L 3 (0.5%)

R 3 (0.5%)

Life Threatening 2 (0.3%)

H 1 (0.2%)

S 1 (0.2%)

Invalid Data 1 (0.2%)

Yearly Trend

1992: 5

1993: 6

1994: 10

1995: 3

1996: 40

1997: 96

1998: 56

1999: 63

2000: 65

2001: 55

2002: 48

2003: 22

2004: 21

2005: 17

2006: 6

2007: 5

2008: 3

2009: 6

2010: 14

2011: 21

2012: 13

2013: 15

2014: 10

2015: 12

2016: 3

2018: 4

2019: 1

Top Manufacturers

RESPIRONICS, INC. 26

RESPIRONICS INC. 9

PHILIPS MEDICAL SYSTEMS 8

Event Locations

365 (58.9%)

NOT APPLICABLE 130 (21.0%)

HOSPITAL 32 (5.2%)

INVALID DATA 28 (4.5%)

HOME 25 (4.0%)

OTHER 21 (3.4%)

I 14 (2.3%)

NO INFORMATION 3 (0.5%)

NURSING HOME 1 (0.2%)

OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare RESPIRONICS, INC. vs RESPIRONICS INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Monitor, Apnea, Facility Use, 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 (620 here).

Integrated Continuous Glucose Monitoring Sy… 620 Accessories, Cleaning Brushes, For Endoscope 621 Bit, Surgical 622 System, Communication, Powered 616

Similar death-typed counts

Nearest other device types by death-typed report count (82 here), distinct from the volume row.

Apparatus, Autotransfusion 82 Device, Monitoring, Intracranial Pressure 82 Catheter, Septostomy 83 Instrument, Ultrasonic Surgical 81

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

Disclaimer: MAUDE figures for Monitor, Apnea, Facility Use 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 Monitor, Apnea, Facility Use; 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.

Monitor, Apnea, Facility Use

Event-type mix vs corpus