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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5700 (General Hospital panel).

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FDA MAUDE casebook

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

#727 of 1000 · 808 reports · 1992–2026

  • BOOK 808 reports
  • RANK #727 of 1000
  • DEATH 2 death-typed
  • INJ 39 injury-typed
  • MALF 732 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 577
  • PHOTO Respiratory Virus Pan…

Nearest event-volume peer: Respiratory Virus Panel Nucleic Acid Assay System (0 report gap)

Unit, Neonatal Phototherapy sits #727 of 1000 among tracked device types with 808 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

Unit, Neonatal Phototherapy carries 90.6% MALFUNCTION-coded reports, 25.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 4.8% corpus 30.3% · below corpus mean (-25.5 pp)
  • MALF 90.6% corpus 64.8% · above corpus mean (+25.8 pp)

Lead product-problem code Overheating of Device is 35% 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 808 MAUDE reports, ranked #727 of 1000.

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

Event Types

Malfunction 732 (90.6%)
Injury 39 (4.8%)
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 567 (67.5%)
189 (22.5%)
Hospitalization 22 (2.6%)
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 421
Melted 419
Device Issue 83
Device Operational Issue 47
Low Test Results 45
Use of Device Problem 22
Output Problem 19
Smoking 17
Unknown (for use when the device problem is not known) 17
Break 13
Energy Output Problem 12
Thermal Decomposition of Device 12
Adverse Event Without Identified Device or Use Problem 11
Device Emits Odor 11
Output below Specifications 11
Electrical /Electronic Property Problem 9
Loose 9
Component Falling 8
Other (for use when an appropriate device code cannot be identified) 8
Sparking 8

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: 3

Reports fell to 3 in 2025, down from an average of 7 in the two years before.

Related Entities for Unit, Neonatal Phototherapy

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 10

Event Locations

I 565 (69.9%)
HOSPITAL 121 (15.0%)
107 (13.2%)
HOME 6 (0.7%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Unit, Neonatal Phototherapy: 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 (808 here).

Respiratory Virus Panel Nucleic Acid Assay… 808 Cannula, Ophthalmic 807 Intracranial Coil-Assist Stent 806 Lithotriptor 811

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 Bed, Pediatric Open Hospital 2 Blade 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.