PlainHospital
2019 data FDA MAUDE openFDA FDA Class II

Monitor, Apnea, Facility Use

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

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §868.2377 (Anesthesiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Monitor, Apnea, Facility Use LIGHT-BOOK · MAUDE

#818 of 1000 · 620 reports · 1992–2019

  • BOOK 620 reports
  • RANK #818 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 #818 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 →

Injury-coded reports sit below the device-type norm

Monitor, Apnea, Facility Use carries 3.4% INJURY-coded reports, 26.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 13.2% corpus 1.5% · above corpus mean (+11.7 pp)
  • INJ 3.4% corpus 30.3% · below corpus mean (-26.9 pp)
  • MALF 79.7% corpus 64.8% · above corpus mean (+14.9 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 .

Monitor, Apnea, Facility Use in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Monitor, Apnea, Facility Use carries 620 MAUDE reports, ranked #818 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

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%)

Top Product Problems

Device Alarm System 189
No Audible Alarm 91
Loss of Power 25
Monitor failure 23
Repair 22
Unknown (for use when the device problem is not known) 20
Alarm, intermittent 19
Defective Alarm 17
Replace 17
Low Audible Alarm 15
Other (for use when an appropriate device code cannot be identified) 15
Alarm, audible 12
Alarm, failure of warning 11
Adverse Event Without Identified Device or Use Problem 9
Device Issue 8
Device Operates Differently Than Expected 8
Loose 8
Corroded 7
Device Displays Incorrect Message 7
Malfunction 7

Yearly Trend

92
1992: 5
93
1993: 6
94
1994: 10
95
1995: 3
96
1996: 40
97
1997: 96
98
1998: 56
99
1999: 63
00
2000: 65
01
2001: 55
02
2002: 48
03
2003: 22
04
2004: 21
05
2005: 17
06
2006: 6
07
2007: 5
08
2008: 3
09
2009: 6
10
2010: 14
11
2011: 21
12
2012: 13
13
2013: 15
14
2014: 10
15
2015: 12
16
2016: 3
18
2018: 4
19
2019: 1

Reports fell to 4 in 2018, down from an average of 8 in the two years before.

Related Entities for Monitor, Apnea, Facility Use

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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Monitor, Apnea, Facility Use: nearest by total report volume and nearest by death-typed count, each 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 Gram-Positive Bacteria And Their Resistance… 621 Cable, Transducer And Electrode, Patient, 622 Nebulizer, Medicinal, Non-Ventilatory 623

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 Instrument, Ultrasonic Surgical 81 Tubing, Pump, Cardiopulmonary Bypass 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.