SideLyer
THE SIDE LYER COMPANY, LLC · Model SLB01 · UDI-DI 00860011685609
Description
The SideLyer Adjustable Patient Bed (APB) is an AC-powered adjustable bed where the caregiver can adjust the bed position at various angles. The SideLyer APB supports patients who are in restricted positions or long term bed use due to lack of mobility or other issues. The APB is moveable, but can be locked in a stationary position. It has a padded horizontal surface and a flat padded vertical surface on one side so that patients can be positioned to lie on their side. The device may be rotated by the patient or caregiver using the device controller at different angles. The benefit of the SideLyer APB’s repositioning to the patient is to relieve or distribute pressure. Repositioning is a fundamental component of pressure ulcer prevention (PUP), including reducing or eliminating bedsores and decubitus ulcers. Repositioning also serves to increase blood flow and transcutaneous oxygen tension, reducing the likelihood of anoxic levels of oxygen and decrease localized interface pressure. Repositioning prevents complications such as pneumonia, joint contractures, and urinary tract infections.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-10 | Kinsman Enterprises Inc | The belt may fail at lower loads than the labeled 600lbs. |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
| 2018-12-19 | Arjohuntleigh Magog | Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute |
| 2014-12-03 | Arjo Hospital Equipment AB | The recalled devices labeling and instructions for use contain unapproved medical claims. |
| 2014-12-03 | Arjo Hospital Equipment AB | The recalled devices labeling and instructions for use contain unapproved medical claims. |
| 2014-12-03 | Arjo Hospital Equipment AB | The recalled devices labeling and instructions for use contain unapproved medical claims. |
| 2013-09-11 | ArjoHuntleigh Inc. | The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient |
| 2011-02-18 | KCI USA, Inc. | Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user. |
| 2010-09-09 | KCI USA, Inc. | Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient. |
| 2005-01-24 | Kinetic Concepts, Inc | To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design. |
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