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.
- Company
- Invacare Corporation
- Recall Initiated
- November 16, 2018
- Terminated
- April 15, 2020
- Recall Number
- Z-0549-2019
- Quantity
- 73,703 units
- Firm Location
- Elyria, OH
Reason for Recall
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.
Distribution
Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
Lot / Code Info
Serial numbers ranging between 09FSZ590001 to 16ESZ104075. Specifically, serial numbers with the following starting values (see below). Each consignee will be receiving an impacted units list, which will include full serial numbers for the units that they have purchased: 10ASZ 11ASZ 12ASZ 13ASZ 14ASZ 15ASZ 16ASZ 10BSZ 11BSZ 12BSZ 13BSZ 14BSZ 15BSZ 16BSZ 10CSZ 11CSZ 12CSZ 13CSZ 14CSZ 15CSZ 16CSZ 10DSZ 11DSZ 12DSZ 13DSZ 14DSZ 15DSZ 16DSZ 10ESSZ 11ESSZ 12ESSZ 13ESSZ 14ESSZ 15ESSZ 16ESSZ 09FSZ 10FSZ 11FSZ 12FSZ 13FSZ 14FSZ 15FSZ 09GSZ 10GSZ 11GSZ 12GSZ 13GSZ 14GSZ 15GSZ 09HSZ 10HSZ 11HSZ 12HSZ 13HSZ 14HSZ 15HSZ 09ISZ 10ISZ 11ISZ 12ISZ 13ISZ 14ISZ 15ISZ 09JSZ 10JSZ 11JSZ 12JSZ 13JSZ 14JSZ 15JSZ 09KSZ 10KSZ 11KSZ 12KSZ 13KSZ 14KSZ 15KSZ 09LSZ 10LSZ 11LSZ 12LSZ 13LSZ 14LSZ 15LSZ
Root Cause
Device Design
Action Taken
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: recall@invacare.com. 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.