| Device Type ID | 2646 |
| Device Name | Unit, Neonatal Phototherapy |
| Regulation Description | Neonatal Phototherapy Unit. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2646 |
| Device | Unit, Neonatal Phototherapy |
| Product Code | LBI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neonatal Phototherapy Unit. |
| CFR Regulation Number | 880.5700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DRAEGER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FANEM LDA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERNATIONAL BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERNATIONAL BIOMEDICAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOLIGHT, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Melted | 412 |
Overheating Of Device | 411 |
Device Issue | 79 |
Device Operational Issue | 47 |
Low Test Results | 45 |
LED (Light Emitting Diode) | 19 |
Output Problem | 17 |
Energy Output Problem | 12 |
Output Below Specifications | 11 |
Electrical /Electronic Property Problem | 8 |
High Test Results | 7 |
Use Of Device Problem | 5 |
Low Readings | 4 |
Device Operates Differently Than Expected | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Output Above Specifications | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Improper Device Output | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Failure To Service | 2 |
Break | 2 |
Device Emits Odor | 2 |
Off-Label Use | 1 |
Misassembly By Users | 1 |
Unexpected Shutdown | 1 |
Current Source | 1 |
Electrical Shorting | 1 |
Calibration Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Thermal Decomposition Of Device | 1 |
Device Inoperable | 1 |
Device Fell | 1 |
Excessive Cooling | 1 |
Potentiometer | 1 |
Circuit Failure | 1 |
Electromagnetic Compatibility Problem | 1 |
| Total Device Problems | 1112 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Medical Incorporated | II | Apr-14-2017 |
| 2 | Natus Medical Incorporated | II | Dec-15-2016 |
| 3 | Natus Medical Incorporated | II | Dec-15-2016 |
| 4 | Natus Medical Incorporated | II | Jun-15-2016 |
| 5 | Natus Medical Incorporated | II | Oct-21-2015 |
| 6 | Natus Medical Incorporated | II | Apr-10-2015 |
| 7 | Natus Medical Incorporated | II | Dec-22-2014 |
| 8 | Ohmeda Medical | II | Mar-20-2017 |
| 9 | Physician Engineered Products, Inc. | II | Aug-31-2015 |