| Device Type ID | 2584 |
| Device Name | Stretcher, Wheeled |
| Regulation Description | Wheeled Stretcher. |
| 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 | 880.6910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FPO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2584 |
| Device | Stretcher, Wheeled |
| Product Code | FPO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Wheeled Stretcher. |
| CFR Regulation Number | 880.6910 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 211 |
Mechanical Jam | 151 |
Unintended Movement | 96 |
Device Fell | 44 |
Device Tipped Over | 28 |
Positioning Problem | 28 |
Difficult Or Delayed Positioning | 27 |
Device Slipped | 20 |
Positioning Failure | 17 |
Sharp Edges | 15 |
Use Of Device Problem | 13 |
Device Operates Differently Than Expected | 13 |
Device Dislodged Or Dislocated | 11 |
Unstable | 9 |
Device Handling Problem | 9 |
Detachment Of Device Component | 8 |
Detachment Of Device Or Device Component | 7 |
Grounding Malfunction | 6 |
Electrical /Electronic Property Problem | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Operational Issue | 3 |
Brake | 3 |
Entrapment Of Device | 3 |
Insufficient Information | 3 |
Break | 3 |
Difficult To Fold Or Unfold | 3 |
Sticking | 3 |
Device Maintenance Issue | 2 |
Peeled / Delaminated | 2 |
Device Issue | 2 |
Intermittent Loss Of Power | 2 |
Difficult To Advance | 2 |
Mechanics Altered | 2 |
Difficult Or Delayed Activation | 2 |
Fastener | 2 |
Cable | 2 |
Device Component Or Accessory | 2 |
Battery | 2 |
Frame | 2 |
Lock | 2 |
Material Integrity Problem | 2 |
Fail-Safe Problem | 2 |
Component Missing | 2 |
No Apparent Adverse Event | 1 |
Mount | 1 |
Component Misassembled | 1 |
Failure To Run On Battery | 1 |
Device Displays Incorrect Message | 1 |
Power Problem | 1 |
Contamination During Use | 1 |
Failure To Service | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Defective Component | 1 |
Device Sensing Problem | 1 |
Electronic Property Issue | 1 |
Human-Device Interface Problem | 1 |
Bent | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Malposition Of Device | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Component Falling | 1 |
Collapse | 1 |
Unintended Head Motion | 1 |
Difficult To Position | 1 |
Load | 1 |
Separation Failure | 1 |
Material Protrusion / Extrusion | 1 |
Patient Device Interaction Problem | 1 |
Wheel | 1 |
Leak / Splash | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Material Deformation | 1 |
| Total Device Problems | 813 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ferno-Washington Inc | II | Apr-15-2017 |
| 2 | Ferno-Washington Inc | II | Oct-01-2015 |
| 3 | Ferno-Washington Inc | II | Aug-25-2015 |
| 4 | Ferno-Washington Inc | II | Jan-16-2015 |
| 5 | Sechrist Industries Inc | II | Jul-01-2015 |
| 6 | Stryker Medical Division Of Stryker Corporation | II | May-02-2018 |
| 7 | Stryker Medical Division Of Stryker Corporation | II | May-01-2018 |
| 8 | Stryker Medical Division Of Stryker Corporation | II | Dec-12-2016 |
| 9 | Stryker Medical Division Of Stryker Corporation | II | Jun-14-2016 |
| 10 | Stryker Medical Division Of Stryker Corporation | II | Mar-17-2016 |