CHG Hospital Beds Recalls Spirit Select Beds Due to Alarm Defect
CHG Hospital Beds is recalling 1,892 Spirit Select beds because the bed exit alarm may fail to function, potentially delaying assistance after a patient fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text reports two injuries and identifies a risk of harm requiring medical intervention, which aligns with the 'High' severity criteria for risk-of-harm products where injury has been reported but the probability is remote.
Plain-English summary
CHG Hospital Beds Inc is recalling 1,892 units of the Spirit Select Med-Surg bed. The recall was initiated because the software code for the bed exit system may erroneously auto-reset. In some situations, the software does not allow enough time for the weight value to fall to zero after a patient leaves the bed, causing the alarm to reset even when no patient is present.
If the bed exit alarm incorrectly resets, medical assistance after a fall or during entanglement may be delayed. A patient fall could result in soft tissue or bone injury requiring medical or surgical intervention. Patients with dementia or disorientation are identified as being at greatest risk. Two injuries have been reported to date associated with these issues.
The affected beds were distributed nationwide in the United States and in Canada. The recall number is Z-1176-2016. Hospitals and healthcare facilities should check their inventory against the list of serial numbers provided in the official recall notice to determine if they possess affected units.
The recalled product
- Product
- 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…
- Manufacturer
- CHG Hospital Beds Inc
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 1,892
Distribution
Distributed nationwide across the United States.
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