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The customer reported a patient developed an unstageable pressure ulcer to the occipital area and a potential deep tissue injury to the left buttock with use of the progressa bed and mattress.There was no report of device malfunction.The current stage of the injuries is unknown, the patient was referred to the tissue viability nurse and the repositioning frequency was increased from every 4 hours to every 2 hours.Medical and/or surgical intervention, if any, was not reported.The patient in this event was a 56-year-old male weighing 108.5 kg and measuring 1.67 m in height.The patient was admitted on the (b)(6) 2023 for a cardiac arrest and has relevant medical history of copd, hypertension and smoking.A purpose t pressure ulcer risk score at the time of the original admission assessment to the icu was (b)(6).The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility, pressure ulcers, or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the progressa bed.Pressure injuries can develop within 2-6 hours when capillaries supplying the skin and subcutaneous tissues are compressed, causing an obstruction in blood flow, which ultimately leads to tissue necrosis.Position changes are key to pressure injury 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.Prevention of pressure injuries involves a multidisciplinary approach including rapid identification of at-risk individuals such as those with diabetes, incontinence, impaired mobility, peripheral vascular disease, etc., and exercising a vigilant prevention protocol consisting of skincare, nutritional assessment reducing mechanical load, and utilizing support surfaces.Pressure ulcers covered with slough or eschar are unstageable by definition.The base of the ulcer needs to be visible in order to properly stage the ulcer, as slough and eschar do not form on stage 1 or stage 2 pressure ulcers, the ulcer will reveal itself as either a stage 3 or stage 4 pressure ulcer.A deep tissue pressure injury is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.In some cases, a dti can resolve in a few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they can develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.A stage 3 pressure injury is defined as full thickness tissue loss.Subcutaneous fat may be visible, but the bone, tendon or muscle are not exposed.Treatment may include prescribed antibiotic therapy and at times removal of any dead tissue to help promote healing and prevent or treat infection.A stage 4 pressure injury involves full thickness skin and tissue loss with exposed or directly palpable fascia, slough, muscle, tendon, ligament, cartilage, or bone in the ulcer.Treatment of stage 4 pressure ulcers begin with the removal of dead tissue.If the damage is extensive, surgery is usually required.In this event, the current stage of the reported injuries is unknown and there was no report of medical and/or surgical intervention required to date.The patient was referred to the tissue viability nurse and the repositioning frequency was increased.However, the reported unstageable pressure injury and potential deep tissue injury meet the definition of a serious injury as they could involve full-thickness skin and/or tissue loss and will likely require medical and or surgical intervention to preclude permanent impairment to body function or permanent damage to body structure.Additionally, there was no allegation of device malfunction, however, an inspection of the device is currently being arranged.At this time, it is undetermined whether the device caused or contributed to the reported injuries.If any additional relevant information is received, the case will be evaluated accordingly.Clinical evaluation revised with the receipt of device inspection details on 7/13/23 the customer reported a patient developed an unstageable pressure ulcer to the occipital area and a potential deep tissue injury to the left buttock with use of the progressa bed and mattress.There was no report of device malfunction.The current stage of the injuries is unknown, the patient was referred to the tissue viability nurse and the repositioning frequency was increased from every 4 hours to every 2 hours.Medical and/or surgical intervention, if any, was not reported.An inspection performed by a hillrom technician noted that there was no malfunction with the device.The technician checked the inner bladders and overall state, pressure measurements were performed with and without load and the bed functioned as designed.In this event, the current stage of the reported injuries is unknown and there was no report of medical and/or surgical intervention required to date.The patient was referred to the tissue viability nurse and the repositioning frequency was increased.Additionally, there was no allegation of device malfunction and no malfunction could be identified upon inspection.Therefore, it is unlikely that the device caused or contributed to a serious injury, and the cause of these pressure injuries is undetermined at this time.However, the reported unstageable pressure injury and potential deep tissue injury meet the definition of a serious injury as they could involve full-thickness skin and/or tissue loss and will likely require medical and or surgical intervention to preclude permanent impairment to body function or permanent damage to body structure.
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