Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
Recall
- Recall Number
- Z-0549-2019
- Event Number
- 81071
- Firm
- Invacare Corporation
- FEI Number
- 1525712
- Product Code
- FSA
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 16, 2018
- Terminated
- April 15, 2020
- Address
- 1200 Taylor St, Elyria, OH, 44035-6248
Description
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolved, the caster may separate from the base of the lift causing the Lift to tilt and a patient fall. Failure does not occur right away but happens over time if the lift is not properly maintained. Patient falls are inherently dangerous and may result in a range of injuries that are dependent on physical condition of the patient and the nature of the fall. When injuries occur, they are typically non-serious injuries such as bruising, lacerations, or abrasions. In rare cases, more serious injuries such as bone fracture, head trauma, or death can occur. For caregivers using the lift, attempts to manually stabilize a lift if it becomes unstable could result in sprains, serious back injuries, or bone fractures.
On November 16, 2018, the firm, INVACARE, distributed "URGENT - MEDICAL DEVICE FIELD ACTION" letters with an attached Technical Bulletin to providers to inform them of the product issue, problems and actions to be taken. Providers are instructed to do the following: 1. Review the included Technical Service Bulletin. 2. Inspect your existing stock for loose fasteners or hardware as required in the user manual. 3. Tighten any loose hardware after inspecting for damage that require replacement of the Lift base. 4. You are responsible for ensuring that this field action is conducted to the customer level. Your customers with affected units should be contacted and informed about this field action. We recommend that you provide them with the enclosed Consumer Letter. 5. Complete and return the Provider Response Card within 5 business days via Fax to: 440-326-3544 or email to: [email protected]. The consumer letters instructed end users to do the following: 1. Continue to have your patient lift(s) inspected and maintained by a qualified service provider at the intervals defined within your User Manual. 2. Continue to check for loose fasteners or hardware prior to each use. 3. Should you find loose fasteners or hardware, contact a qualified service provider to perform maintenance. Do not attempt to perform maintenance yourself. If you have any questions concerning these instructions, please call Invacares recall and field action support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance.
Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
73,703 units