This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
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It was reported to the manufacturer, by the end user, per the end user, that facility requested a service for a deflating air mattress.She said that the nurses have been complaining that it kept deflating.There was an incident where the patient fell out of the bed because it deflated on one side.The incident occurred on (b)(6) 2022.She said they have an in-house doctor that checked the patient out after the fall and he determined that the patient was ok, no injuries.Complaint (b)(4) was entered into our system to have the mattress returned for investigation.As of this writing, the product has not been returned.
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