Definition: A Bed Intended For Obese Patients Weighing 500 Pounds And Above. Beds Can Expand From 38 To 60 Inches In Width.
| Device Type ID | 2727 |
| Device Name | Bariatric Bed |
| Physical State | Bed |
| Technical Method | Bed |
| Target Area | Bed |
| Regulation Description | AC-powered Adjustable Hospital Bed. |
| 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) Exempt |
| CFR Regulation Number | 880.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2727 |
| Device | Bariatric Bed |
| Product Code | OSI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Adjustable Hospital Bed. |
| CFR Regulation Number | 880.5100 [🔎] |
| Device Problems | |
|---|---|
Break | 8 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Unintended System Motion | 3 |
Smoking | 3 |
Use Of Device Problem | 3 |
Fire | 3 |
Thermal Decomposition Of Device | 2 |
Electrical Wire | 2 |
Sticking | 2 |
Unintended Movement | 1 |
Device Emits Odor | 1 |
Inadequate Or Insufficient Training | 1 |
Human Factors Issue | 1 |
Device Handling Problem | 1 |
Sharp Edges | 1 |
Entrapment Of Device | 1 |
Collapse | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
Sparking | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Bent | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Melted | 1 |
Caster | 1 |
Electrical /Electronic Property Problem | 1 |
| Total Device Problems | 55 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SCM True Air Technologies LLC | II | May-19-2014 |