TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible

FDA device recall Z-1794-2013 · posted 2013-07-23 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

Reason for recall

When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.

Action taken

The firm, Hill-Rom, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 29, 2013 was sent to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Until the correction is implemented, after placing the bed into chair position, regularly check the foot section of the mattress. If necessary, push it back against the bed frame until the magnets hold it in place before allowing the patient to get back into or out of bed. In addition, forward a copy of this letter to any other facility personnel you deem appropriate. If you have any questions concerning this notification, please contact your distributor, your Hill-Rom representative, or Hill-Rom Technical Support at 800-445-3720 (Mon-Thurs, 8 am-6:30 pm; Friday, 8 am-6 pm).

Root cause

Device Design

Status

Terminated

Product code

IOQ

Quantity affected

4,121 Units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.

Date initiated

2013-05-30

Date posted

2013-07-23

Date terminated

2014-04-17

Location

Batesville, IN