It was reported by the customer that a patient developed a stage 3 pressure ulcer of the sacral region and a stage 1 pressure ulcer of the heel region coincident with use of the progressa bed.Specific details including medical intervention, if the pressure ulcers were pre-existing, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.There was no allegation of a device malfunction reported.This evaluation addresses patient 1 of 2.This report was filed in our complaint handling system as complaint # (b)(4).
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It was reported by the customer that a patient developed a stage 3 pressure ulcer of the sacral region and a stage 1 pressure ulcer of the heel region coincident with use of the progressa bed.Specific details including medical intervention, if the pressure ulcers were pre-existing, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.There was no allegation of a device malfunction reported.This evaluation addresses patient 1 of 2.The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa bed is intended to provide a patient support to be used in health care environments.The progressa bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The progressa bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Instructions for use state ¿the therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.¿ development of pressure ulcers is multifactorial and cannot be only attributed to performance of the surface.Risk factors include protein-calorie malnutrition, microclimate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy.Position changes are key to pressure sore prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.The hillrom service technician inspected the bed, and no technical problems were found.The bed functioned as designed.A stage 1 pressure injury is categorized as intact skin with non-blanchable redness of a localized area that may be painful, however, has no breaks or tears.A stage 1 pressure injury is considered a moderate injury as it does not meet the definition of serious injury as it is not life threatening; does not result in permanent impairment of a body function or permanent damage to a body structure; and application of dermal creams or coverings does not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.A stage 3 pressure injury is categorized as full thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.A stage 3 pressure injury often requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore meets the definition of a serious injury.Attempts to obtain additional details of the pressure injury including medical intervention provided and patient outcome are ongoing.If additional relevant information is received, the complaint will be reassessed.Hillrom considers this complaint a reportable serious injury.Based on this information, no further action is required.
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