2026 data FDA MAUDE openFDA FDA Class I

Monitor, Bed Patient

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.2400 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Monitor, Bed Patient LIGHT-BOOK · MAUDE

#383 of 1000 · 3,238 reports · 1992–2026

  • BOOK 3,238 reports
  • RANK #383 of 1000
  • DEATH 80 death-typed
  • INJ 291 injury-typed
  • MALF 2,779 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 510
  • PHOTO Chair, With Casters

Nearest event-volume peer: Chair, With Casters (3 report gap)

Monitor, Bed Patient sits #383 of 1000 among tracked device types with 3,238 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Monitor, Bed Patient carries 9.0% INJURY-coded reports, 21.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 9.0% corpus 30.3% · below corpus mean (-21.3 pp)
  • MALF 85.8% corpus 64.8% · above corpus mean (+21.0 pp)

Lead product-problem code Device Alarm System is 39% of coded problems · Top event location is 86% of location-tagged rows .

Monitor, Bed Patient in the event-volume neighbourhood

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

reports

What this shows Monitor, Bed Patient carries 3,238 MAUDE reports, ranked #383 of 1000.

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

Event Types

Malfunction 2,779 (85.8%)
Injury 291 (9.0%)
Death 80 (2.5%)
Other 61 (1.9%)
27 (0.8%)

Patient Outcomes

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

2,760 (82.8%)
Other 172 (5.2%)
Hospitalization 151 (4.5%)
Death 76 (2.3%)
Required Intervention 71 (2.1%)
R 53 (1.6%)
O 14 (0.4%)
S 13 (0.4%)
H 7 (0.2%)
L 7 (0.2%)
Life Threatening 5 (0.2%)
Invalid Data 2 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Device Alarm System 1,164
No Audible Alarm 357
Failure to Power Up 280
Unknown (for use when the device problem is not known) 166
Alarm, intermittent 138
Other (for use when an appropriate device code cannot be identified) 124
Loss of Power 105
Break 101
Failure to Sense 90
Device Operates Differently Than Expected 75
False Alarm 61
Loose or Intermittent Connection 54
Component Missing 50
Defective Alarm 45
Device Stops Intermittently 40
Alarm, failure of warning 38
Battery Problem 33
Insufficient Device Problem Information 29
Delayed Alarm 24
Adverse Event Without Identified Device or Use Problem 23

Yearly Trend

92
1992: 5
93
1993: 3
94
1994: 4
95
1995: 5
96
1996: 28
97
1997: 37
98
1998: 31
99
1999: 18
00
2000: 23
01
2001: 31
02
2002: 28
03
2003: 25
04
2004: 20
05
2005: 30
06
2006: 16
07
2007: 20
08
2008: 76
09
2009: 510
10
2010: 329
11
2011: 379
12
2012: 421
13
2013: 400
14
2014: 358
15
2015: 34
16
2016: 24
17
2017: 30
18
2018: 28
19
2019: 14
20
2020: 17
21
2021: 14
22
2022: 21
23
2023: 35
24
2024: 69
25
2025: 84
26
2026: 71

Reports rose to 84 in 2025, up from an average of 52 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Monitor, Bed Patient

Event Locations

2,784 (86.0%)
HOSPITAL 237 (7.3%)
NURSING HOME 106 (3.3%)
I 68 (2.1%)
INVALID DATA 14 (0.4%)
NO INFORMATION 14 (0.4%)
HOME 5 (0.2%)
OTHER 5 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOSPICE 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
UNKNOWN 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Monitor, Bed Patient: 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 (3,238 here).

Similar death-typed counts

Nearest other device types by death-typed report count (80 here), distinct from the volume row.

Disclaimer: MAUDE figures for Monitor, Bed Patient 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, Bed Patient; 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.