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2026 data FDA MAUDE openFDA

Unit, Neonatal Phototherapy

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.

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FDA MAUDE casebook

openFDA event book Unit, Neonatal Phototherapy LIGHT-BOOK · MAUDE

#713 of 1000 · 806 reports · 1992–2026

  • BOOK 806 reports
  • RANK #713 of 1000
  • DEATH 2 death-typed
  • INJ 38 injury-typed
  • MALF 731 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 577
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Hemodialysis, Triple Lumen, Non-Implanted (0 report gap)

Unit, Neonatal Phototherapy sits #713 of 1000 among tracked device types with 806 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 4.7% corpus 30.4% · below corpus mean (-25.7 pp)
  • MALF 90.7% corpus 64.5% · above corpus mean (+26.2 pp)

Lead product-problem code Overheating of Device is 37% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 100% of manufacturer-tagged reports · Top event location I is 70% of location-tagged rows .

Unit, Neonatal Phototherapy in the event-volume neighbourhood

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

reports

What this shows Unit, Neonatal Phototherapy carries 806 MAUDE reports, ranked #713 of 1000.

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

Event Types

Malfunction 731 (90.7%)
Injury 38 (4.7%)
Other 28 (3.5%)
7 (0.9%)
Death 2 (0.2%)

Patient Outcomes

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

Other 566 (67.5%)
189 (22.6%)
Hospitalization 21 (2.5%)
O 18 (2.1%)
Required Intervention 18 (2.1%)
L 9 (1.1%)
Life Threatening 9 (1.1%)
R 4 (0.5%)
Death 2 (0.2%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Overheating of Device 416
Melted 415
Device Issue 79
Device Operational Issue 47
Low Test Results 45
Output Problem 18
Energy Output Problem 12
Output below Specifications 11
Use of Device Problem 11
Adverse Event Without Identified Device or Use Problem 8
Electrical /Electronic Property Problem 8
High Test Results 7
Device Emits Odor 6
Device Operates Differently Than Expected 6
Device Fell 5
Detachment of Device or Device Component 4
Device Dislodged or Dislocated 4
Low Readings 4
Temperature Problem 4
Thermal Decomposition of Device 4

Yearly Trend

92
1992: 1
96
1996: 5
97
1997: 5
98
1998: 9
99
1999: 7
00
2000: 3
01
2001: 15
02
2002: 7
03
2003: 2
04
2004: 11
05
2005: 18
06
2006: 12
07
2007: 1
08
2008: 4
09
2009: 4
10
2010: 9
11
2011: 5
12
2012: 3
13
2013: 6
14
2014: 5
15
2015: 6
16
2016: 22
17
2017: 577
18
2018: 37
19
2019: 6
20
2020: 6
21
2021: 2
22
2022: 8
24
2024: 6
25
2025: 3
26
2026: 1

Related Entities for Unit, Neonatal Phototherapy

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 10

Event Locations

I 565 (70.1%)
HOSPITAL 121 (15.0%)
106 (13.2%)
HOME 5 (0.6%)
NO INFORMATION 5 (0.6%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Unit, Neonatal Phototherapy, 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 (806 here).

Catheter 806 Dislodger, Stone, Biliary 806 Respiratory Virus Panel Nucleic Acid Assay… 807 Applicator, Absorbent Tipped, Sterile 810

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

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

Disclaimer: MAUDE figures for Unit, Neonatal Phototherapy 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 Unit, Neonatal Phototherapy; 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.