FDAFebruary 18, 2015device

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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