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It was reported that a patient developed a stage 3 pressure injury in the coccyx area after using the progressa bed for 1 week.The bed was inspected, and no malfunction was identified, the bed's pressures were found in the expected ranges.The device inspection also noted the patient's initial weight had not been set, and rotation therapy was not being used consistently.Specific details of the event including medical/surgical intervention provided, the patient¿s medical history, accessory devices utilized, and the facility's positioning protocols were not provided.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.Additionally, the instructions for use (ifu) states 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.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.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.In this event, the stage 3 pressure injury to the patient's coccyx area meets the definition of a serious injury.There was no report of device malfunction and the bed's pressures were noted to be in the expected ranges.Additionally, the device ifu provides complete instructions on the use of the bed.Based on the information provided, there is no indication that a malfunction of the progressa bed caused or contributed to the reported injury, however, use error cannot be ruled out, as the bed inspection noted the patient's weight had not been set, and rotation therapy was not being used consistently.Prevention of this type of events is outlined in the device ifu.If additional relevant information is received, the complaint will be reassessed.
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It was reported that a patient developed a stage 3 pressure injury in the coccyx area after using the progressa bed for 1 week.The bed was inspected, and no malfunction was identified, the bed's pressures were found in the expected ranges.The device inspection also noted the patient's initial weight had not been set, and rotation therapy was not being used consistently.This report was filed in our complaint handling system as complaint # (b)(4).
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