| Device Type ID | 2607 |
| Device Name | Lift, Patient, Non-ac-powered |
| Regulation Description | Non-AC-powered Patient Lift. |
| 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 | 880.5510 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FSA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2607 |
| Device | Lift, Patient, Non-ac-powered |
| Product Code | FSA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-AC-powered Patient Lift. |
| CFR Regulation Number | 880.5510 [🔎] |
| Device Problems | |
|---|---|
Use Of Device Problem | 357 |
Detachment Of Device Component | 296 |
Break | 207 |
Adverse Event Without Identified Device Or Use Problem | 206 |
Detachment Of Device Or Device Component | 159 |
Device Tipped Over | 121 |
Mechanical Problem | 102 |
Unintended Movement | 90 |
Device Handling Problem | 82 |
Component Falling | 73 |
Inadequate Or Insufficient Training | 36 |
Installation-Related Problem | 35 |
Material Separation | 29 |
Bent | 29 |
Human Factors Issue | 25 |
Material Rupture | 24 |
Device Operates Differently Than Expected | 22 |
Improper Or Incorrect Procedure Or Method | 22 |
Maintenance Does Not Comply To Manufacturers Recommendations | 18 |
Insufficient Information | 17 |
Fracture | 16 |
Material Integrity Problem | 13 |
Unstable | 12 |
Device Issue | 12 |
Material Deformation | 12 |
Device Maintenance Issue | 10 |
Crack | 10 |
Device Inoperable | 10 |
Battery Problem | 10 |
Electrical /Electronic Property Problem | 10 |
Device Fell | 9 |
Actuator | 9 |
Leak / Splash | 9 |
Torn Material | 8 |
Device Operational Issue | 8 |
Material Frayed | 8 |
Caster | 8 |
Device Dislodged Or Dislocated | 7 |
Component Missing | 7 |
Defective Component | 7 |
Solder Joint Fracture | 7 |
Partial Blockage | 7 |
Off-Label Use | 6 |
Device Slipped | 6 |
Failure To Service | 6 |
Inadequate Service | 6 |
Failure To Align | 5 |
Inadequacy Of Device Shape And/or Size | 5 |
Electrical Shorting | 4 |
Material Fragmentation | 4 |
Mechanical Jam | 4 |
Naturally Worn | 4 |
Mechanics Altered | 4 |
Flaked | 4 |
Loose Or Intermittent Connection | 4 |
No Apparent Adverse Event | 4 |
Material Split, Cut Or Torn | 4 |
Human-Device Interface Problem | 4 |
Material Twisted / Bent | 3 |
Device Component Or Accessory | 3 |
Bolt | 3 |
Corroded | 3 |
Frame | 3 |
Smoking | 3 |
Fail-Safe Problem | 3 |
None | 3 |
Misassembled | 3 |
Thermal Decomposition Of Device | 3 |
Disconnection | 3 |
Positioning Problem | 3 |
Switch, Push Button | 3 |
Device Damaged Prior To Use | 3 |
Cut In Material | 3 |
Collapse | 3 |
Shelf Life Exceeded | 3 |
Component Incompatible | 3 |
Out-Of-Box Failure | 3 |
Accessory Incompatible | 3 |
Motor | 2 |
Dent In Material | 2 |
Clip | 2 |
Wheel | 2 |
Misassembly By Users | 2 |
Unintended Arm Motion | 2 |
Fluid Leak | 2 |
Defective Device | 2 |
Noise, Audible | 2 |
Weld | 2 |
Appropriate Term/Code Not Available | 2 |
Structural Problem | 2 |
Resistance, Loss Of | 2 |
Misconnection | 2 |
Product Quality Problem | 2 |
Fail-Safe Did Not Operate | 2 |
Sparking | 2 |
Unintended Electrical Shock | 1 |
Misassembled During Installation | 1 |
Handpiece | 1 |
Mechanism | 1 |
Device Stops Intermittently | 1 |
| Total Device Problems | 2332 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. | II | Sep-16-2014 |
| 2 | ARJOHUNTLEIGH POLSKA Sp. Z.o.o. | II | Dec-07-2018 |
| 3 | ARJOHUNTLEIGH POLSKA Sp. Z.o.o. | II | Sep-24-2014 |
| 4 | Arjo, Inc. Dba ArjoHuntleigh | II | Apr-14-2016 |
| 5 | Arjo, Inc. Dba ArjoHuntleigh | II | Oct-17-2014 |
| 6 | Arjohuntleigh Magog | II | Aug-07-2018 |
| 7 | Autochair | II | Apr-18-2018 |
| 8 | ErgoSafe Product LLC Dba Prism Medical Services | II | Apr-10-2014 |
| 9 | ErgoSafe Products, LLC (DBA) Prism Medical | II | Feb-28-2017 |
| 10 | ErgoSafe Products, LLC (DBA) Prism Medical | II | Dec-09-2016 |
| 11 | ErgoSafe Products, LLC (DBA) Prism Medical | II | Nov-17-2015 |
| 12 | ErgoSafe Products, LLC (DBA) Prism Medical | II | Jul-27-2015 |
| 13 | Handicare AB | II | Oct-11-2017 |
| 14 | Handicare Usa Inc | II | Sep-15-2017 |
| 15 | Hill-Rom, Inc. | II | Oct-31-2016 |
| 16 | Hill-Rom, Inc. | II | Jun-07-2016 |
| 17 | Hill-Rom, Inc. | II | Jun-19-2015 |
| 18 | Invacare Corporation | II | Dec-03-2018 |
| 19 | Liko AB | II | Oct-12-2018 |
| 20 | Moller Vital | II | Jul-26-2016 |