2026 data FDA MAUDE openFDA FDA Class II

Table, Obstetric (And Accessories)

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 §884.4900 (Obstetrics/Gynecology panel).

FDA MAUDE casebook

openFDA event book Table, Obstetric LIGHT-BOOK · MAUDE

#826 of 1000 · 602 reports · 1992–2026

  • BOOK 602 reports
  • RANK #826 of 1000
  • DEATH 0 death-typed
  • INJ 11 injury-typed
  • MALF 569 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 114
  • PHOTO Probe

Nearest event-volume peer: Probe (0 report gap)

Table, Obstetric (And Accessories) sits #826 of 1000 among tracked device types with 602 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 →

Malfunction reports run above the device-type norm

Table, Obstetric carries 94.5% MALFUNCTION-coded reports, 29.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
  • MALF 94.5% corpus 64.8% · above corpus mean (+29.7 pp)

Lead product-problem code Unintended Movement is 44% of coded problems · Lead manufacturer HILL-ROM BATESVILLE accounts for 46% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Table, Obstetric in the event-volume neighbourhood

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

reports

What this shows Table, Obstetric (And Accessories) carries 602 MAUDE reports, ranked #826 of 1000.

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

Event Types

Malfunction 569 (94.5%)
Other 21 (3.5%)
Injury 11 (1.8%)
1 (0.2%)

Patient Outcomes

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

574 (95.3%)
Other 23 (3.8%)
Required Intervention 3 (0.5%)
Hospitalization 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Unintended Movement 264
Device Slipped 88
Material Split, Cut or Torn 66
Activation Problem 29
Unintended System Motion 25
Loose or Intermittent Connection 22
Component Falling 20
Self-Activation or Keying 14
Defective Component 12
Break 7
Collapse 6
Component(s), broken 6
Device Alarm System 6
Device Operates Differently Than Expected 6
Detachment Of Device Component 5
Unknown (for use when the device problem is not known) 5
No Audible Alarm 4
Disconnection 3
Intermittent Continuity 3
Loose 3

Yearly Trend

92
1992: 1
96
1996: 1
97
1997: 1
98
1998: 4
99
1999: 3
00
2000: 1
01
2001: 1
02
2002: 17
03
2003: 2
04
2004: 3
05
2005: 8
06
2006: 13
07
2007: 1
08
2008: 1
12
2012: 4
13
2013: 1
14
2014: 11
15
2015: 15
17
2017: 2
18
2018: 37
19
2019: 60
20
2020: 44
21
2021: 25
22
2022: 25
23
2023: 45
24
2024: 71
25
2025: 114
26
2026: 91

Reports rose to 114 in 2025, up from an average of 58 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Table, Obstetric (And Accessories)

Event Locations

420 (69.8%)
I 163 (27.1%)
HOSPITAL 18 (3.0%)
UNKNOWN 1 (0.2%)

Compare HILL-ROM BATESVILLE vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with a comparable report-volume footprint

Table, Obstetric carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (602 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Table, Obstetric 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 Table, Obstetric; 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.