PlainHospital
2026 data FDA MAUDE openFDA

Catheter, Oximeter, Fiber-Optic

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Catheter, Oximeter, Fiber-Optic LIGHT-BOOK · MAUDE

#644 of 1000 · 1,047 reports · 1992–2026

  • BOOK 1,047 reports
  • RANK #644 of 1000
  • DEATH 24 death-typed
  • INJ 122 injury-typed
  • MALF 882 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 79
  • PHOTO System

Nearest event-volume peer: System, Tomography, Computed, Emission (3 report gap)

Catheter, Oximeter, Fiber-Optic sits #644 of 1000 among tracked device types with 1,047 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 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 11.7% corpus 30.4% · below corpus mean (-18.8 pp)
  • MALF 84.2% corpus 64.5% · above corpus mean (+19.7 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 28% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 58% of manufacturer-tagged reports · Top event location HOSPITAL is 37% of location-tagged rows .

Catheter, Oximeter, Fiber-Optic in the event-volume neighbourhood

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

reports

What this shows Catheter, Oximeter, Fiber-Optic carries 1,047 MAUDE reports, ranked #644 of 1000.

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

Event Types

Malfunction 882 (84.2%)
Injury 122 (11.7%)
Death 24 (2.3%)
Other 14 (1.3%)
5 (0.5%)

Patient Outcomes

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

821 (76.8%)
Other 139 (13.0%)
Required Intervention 45 (4.2%)
Death 26 (2.4%)
R 9 (0.8%)
Hospitalization 7 (0.7%)
Life Threatening 6 (0.6%)
L 5 (0.5%)
H 4 (0.4%)
Disability 4 (0.4%)
O 3 (0.3%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 134
Material Rupture 73
Incorrect Measurement 42
Leak/Splash 37
Fluid/Blood Leak 32
Adverse Event Without Identified Device or Use Problem 29
Appropriate Term/Code Not Available 15
Deflation Problem 12
Difficult to Insert 12
Break 11
Inflation Problem 11
Material Split, Cut or Torn 11
Material Separation 10
Output Problem 9
Material Fragmentation 8
Unable to Obtain Readings 8
Detachment of Device or Device Component 7
Device Contamination with Chemical or Other Material 7
Kinked 7
No Device Output 6

Yearly Trend

92
1992: 1
96
1996: 3
97
1997: 18
98
1998: 18
99
1999: 16
00
2000: 24
01
2001: 13
02
2002: 16
03
2003: 10
04
2004: 4
05
2005: 3
06
2006: 5
07
2007: 20
08
2008: 12
09
2009: 51
10
2010: 64
11
2011: 54
12
2012: 79
13
2013: 58
14
2014: 38
15
2015: 58
16
2016: 68
17
2017: 47
18
2018: 38
19
2019: 63
20
2020: 39
21
2021: 39
22
2022: 57
23
2023: 48
24
2024: 47
25
2025: 31
26
2026: 5

Related Entities for Catheter, Oximeter, Fiber-Optic

Top Manufacturers

EDWARDS LIFESCIENCES, PR 561
EDWARDS LIFESCIENCES PR 136
ABBOTT LABORATORIES 106
ICU MEDICAL, INC. 74
EDWARDS LIFESCIENCES 49
EDWARDS LIFESCIENCES LLC 21
HOSPIRA, INC. 11
ICU MEDICAL INC. 6

Event Locations

HOSPITAL 388 (37.1%)
352 (33.6%)
I 296 (28.3%)
NO INFORMATION 6 (0.6%)
UNKNOWN 3 (0.3%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)

Compare EDWARDS LIFESCIENCES, PR vs EDWARDS LIFESCIENCES PR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Oximeter, Fiber-Optic, 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 (1,047 here).

System, Tomography, Computed, Emission 1,050 Lithotriptor, Ultrasonic 1,051 Prosthesis, Rib Replacement 1,038 Drill, Bone, Powered 1,033

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Apparatus, Suction, Patient Care 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24 Mesh 24

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

Disclaimer: MAUDE figures for Catheter, Oximeter, Fiber-Optic 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 Catheter, Oximeter, Fiber-Optic; 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.