Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transpor

FDA device recall Z-1651-2008 · posted 2008-08-28 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.

Action taken

Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

3 lifts

Distribution

Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA

Date initiated

2008-05-05

Date posted

2008-08-28

Date terminated

2010-02-03

Location

Roselle, IL