The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medi

FDA device recall Z-1176-2016 · posted 2016-03-15 · Terminated

Recall details

Recalling firm

CHG Hospital Beds Inc

Reason for recall

It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. In some situations, the software code does not allow enough time for the weight value to fall to zero once the patient egresses from the bed, in which case, the bed has the potential to reset the bed exit alarm even without a patient on the bed. The bed exit on the Spirit Select bed may incorrectly reset if the Auto Reset option is selected. A patient fall may result in soft tissue or bone injury which may require medical or surgical intervention to prevent permanent disability. If the bed exit alarm incorrectly resets then medical assistance after a fall or during entanglement may be delayed. Patients with dementia or disorientation are at greatest risk. There have been two reported injuries associated with these issues to date. A Medical Risk Assessment determined that there is a remote probability of occurrence of harm requiring medical intervention.

Action taken

On 2/18/2016, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Root cause

Software design

Status

Terminated

Product code

FNL

Quantity affected

1892

Distribution

Distributed US (nationwide) and in Canada.

Date initiated

2015-02-18

Date posted

2016-03-15

Date terminated

2017-05-23

Location

London, Canada