| Device Type ID | 2559 |
| Device Name | Warmer, Infant Radiant |
| Regulation Description | Infant Radiant Warmer. |
| 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 | 880.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMT |
| 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 | 2559 |
| Device | Warmer, Infant Radiant |
| Product Code | FMT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infant Radiant Warmer. |
| CFR Regulation Number | 880.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTERNATIONAL BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERNATIONAL BIOMEDICAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Crack | 59 |
Device Issue | 27 |
No Audible Alarm | 22 |
Electrical /Electronic Property Problem | 17 |
Material Integrity Problem | 9 |
Output Problem | 7 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 6 |
Device Alarm System | 5 |
Failure To Adhere Or Bond | 5 |
Device Displays Incorrect Message | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Low Readings | 4 |
Display Or Visual Feedback Problem | 3 |
Device Handling Problem | 3 |
Break | 2 |
Thermal Decomposition Of Device | 2 |
Unable To Obtain Readings | 2 |
Improper Device Output | 2 |
Use Of Device Problem | 2 |
Physical Property Issue | 2 |
Appropriate Term/Code Not Available | 2 |
No Apparent Adverse Event | 1 |
Connection Problem | 1 |
High Readings | 1 |
Medical Gas Supply Problem | 1 |
Device Operational Issue | 1 |
Transport | 1 |
Mechanical Problem | 1 |
Insufficient Information | 1 |
Patient Device Interaction Problem | 1 |
Alarm Not Visible | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
| Total Device Problems | 202 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DeRoyal Industries Inc | II | Nov-30-2015 |
| 2 | Draeger Medical, Inc. | II | Jul-28-2016 |
| 3 | Fisher & Paykel Healthcare, Ltd. | II | Nov-13-2014 |
| 4 | GE Healthcare | II | May-06-2014 |
| 5 | GE Healthcare | II | Feb-03-2014 |
| 6 | GE Healthcare, LLC | II | Nov-19-2018 |
| 7 | GE Healthcare, LLC | II | May-19-2017 |
| 8 | GE Healthcare, LLC | II | Jan-11-2017 |
| 9 | Ohmeda Medical | II | Mar-20-2017 |