| Device Type ID | 2565 |
| Device Name | Bed, Ac-powered Adjustable Hospital |
| 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 | FNL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2565 |
| Device | Bed, Ac-powered Adjustable Hospital |
| Product Code | FNL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Adjustable Hospital Bed. |
| CFR Regulation Number | 880.5100 [🔎] |
| Device Problems | |
|---|---|
Incorrect Measurement | 102 |
Unintended Movement | 98 |
Electrical /Electronic Property Problem | 93 |
Break | 92 |
Adverse Event Without Identified Device Or Use Problem | 82 |
Mechanical Problem | 80 |
Component Missing | 60 |
Use Of Device Problem | 48 |
Unintended System Motion | 47 |
Material Integrity Problem | 28 |
Device Fell | 28 |
No Audible Alarm | 26 |
Detachment Of Device Component | 25 |
Detachment Of Device Or Device Component | 24 |
Collapse | 23 |
Device Operates Differently Than Expected | 23 |
Bent | 20 |
Device Inoperable | 19 |
Component Falling | 18 |
Device Alarm System | 16 |
Insufficient Information | 15 |
Human Factors Issue | 14 |
Unstable | 13 |
Frame | 13 |
Weld | 10 |
Peeled / Delaminated | 10 |
Side Rail | 9 |
Sharp Edges | 8 |
Material Separation | 8 |
Device Handling Problem | 7 |
Device Maintenance Issue | 7 |
Sensor | 7 |
Entrapment Of Device | 7 |
Crack | 7 |
Fracture | 7 |
Rail | 6 |
Failure To Sense | 6 |
Sparking | 6 |
Smoking | 6 |
Appropriate Term/Code Not Available | 6 |
Calibration Problem | 6 |
Device Slipped | 6 |
Unintended Head Motion | 5 |
Loose Or Intermittent Connection | 5 |
Housing | 5 |
Alarm Not Visible | 5 |
Intermittent Loss Of Power | 5 |
Device Issue | 5 |
Device Dislodged Or Dislocated | 5 |
Bearings | 5 |
Latch | 5 |
Brake | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Device Sensing Problem | 4 |
Product Quality Problem | 4 |
Fire | 4 |
Delamination | 4 |
Inadequate Or Insufficient Training | 4 |
Spring | 4 |
Device Misassembled During Manufacturing / Shipping | 4 |
Material Deformation | 3 |
Device Subassembly | 3 |
Mechanics Altered | 3 |
Naturally Worn | 3 |
Device Tipped Over | 3 |
Scale | 3 |
Caster | 3 |
Mount | 3 |
Device Operational Issue | 3 |
Human-Device Interface Problem | 3 |
Device Stops Intermittently | 3 |
Difficult To Remove | 2 |
Non Reproducible Results | 2 |
Material Frayed | 2 |
Failure To Charge | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Or Inadequate Test Results | 2 |
Scratched Material | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Arcing | 2 |
Power Cord | 2 |
Delayed Alarm | 2 |
Out-Of-Box Failure | 2 |
Plate | 2 |
Installation-Related Problem | 2 |
Protective Measures Problem | 1 |
Locking Mechanism | 1 |
Misassembly By Users | 1 |
Device Damaged By Another Device | 1 |
Tube | 1 |
Component Incompatible | 1 |
Failure To Power Up | 1 |
Off-Label Use | 1 |
Prong | 1 |
Knob | 1 |
Motor | 1 |
Sticking | 1 |
Failure To Zero | 1 |
Fail-Safe Design Failure | 1 |
Thermal Decomposition Of Device | 1 |
| Total Device Problems | 1295 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arjo Hospital Equipment AB | II | Oct-06-2014 |
| 2 | CHG Hospital Beds Inc | II | Aug-03-2016 |
| 3 | CHG Hospital Beds Inc | II | Mar-15-2016 |
| 4 | GF Health Products, Inc | II | Dec-12-2016 |
| 5 | GF Health Products, Inc./d.b.a.Basic American Metal Products | II | Sep-16-2014 |
| 6 | Handicare Usa Inc | II | Aug-20-2018 |
| 7 | Hill-Rom, Inc. | II | Apr-09-2018 |
| 8 | Hill-Rom, Inc. | II | Apr-12-2017 |
| 9 | Hill-Rom, Inc. | II | Aug-09-2016 |
| 10 | Hill-Rom, Inc. | II | Nov-13-2015 |
| 11 | Hill-Rom, Inc. | II | Jun-26-2015 |
| 12 | Invacare Corporation | II | Aug-11-2016 |
| 13 | Invacare Corporation | II | Feb-02-2015 |
| 14 | Joerns Healthcare | II | Oct-30-2014 |
| 15 | Med-Mizer, Inc. | II | Sep-17-2018 |
| 16 | Med-Mizer, Inc. | II | May-02-2014 |
| 17 | Primus Medical LLC | II | Oct-15-2014 |
| 18 | Stryker Medical Division Of Stryker Corporation | II | Nov-09-2018 |
| 19 | Stryker Medical Division Of Stryker Corporation | II | Aug-08-2016 |
| 20 | Stryker Medical Division Of Stryker Corporation | II | Apr-22-2016 |
| 21 | Stryker Medical Division Of Stryker Corporation | II | Apr-22-2016 |
| 22 | Stryker Medical Division Of Stryker Corporation | II | Jul-28-2014 |
| 23 | Vitalgo Inc. | II | Aug-09-2018 |