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The customer reported that the patient developed a stage 3 occiput and bilateral heel stage 0 pressure injuries associated with the use of the progressa bed.It is noted that the patient was admitted to the hospital on (b)(6) 2023 and noted to have the reported pressure injury on (b)(6) 2023 (heel) and (b)(6) 2023 (occiput).Specific details of the event including clarification if the associated pressure injury were preexisting, the medical treatment provided for the pressure injury, the patient¿s medical history, accessory devices utilized, and facilities positioning protocols were not provided.This report was filed in our complaint handling system as complaint (b)(4).
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The customer reported that the patient developed a stage 3 occiput and bilateral heel stage 0 pressure injuries associated with the use of the progressa bed.It is noted that the patient was admitted to the hospital on (b)(6) 2023 and noted to have the reported pressure injury on (b)(6) 2023 (heel) and (b)(6) 2023 (occiput).Specific details of the event including clarification if the associated pressure injuries were preexisting, the medical treatment provided for the pressure injuries, 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.Pressure injuries are often staged or categorized on a number system ranking in severity from 1-4.A reported stage of "0" would suggest that there was no presence of a pressure injury per se, but likely evidence of localized pressure on the area.It is reasonable to conclude that the report of a zero-staged area would be a precursor to a pressure injury, with characteristics including an intact blanchable reddened area of the skin.A reddened area of the skin is the first symptom of pressure on your skin, a warning signal.Once the pressure is removed, the redness fades and no damage has occurred.Redness is not a serious injury and does not require 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.In this event, the stage 3 injury to the occiput meets the definition of a serious injury.At the time of this evaluation, causality of the reported pressure injury is undetermined as the investigation is ongoing to determine specific details of the reported event.There was no allegation of a device malfunction, and it is noted that this bed has been inspected on multiple occasions surrounding the timeframe of the customer¿s allegation.The inspections found the bed to have no technical issues and to be functioning as designed.The customer has expressed, however, difficulty in using the progressa bed compared to other bed models (hillrom and other vendor), noting that the beds are ¿too complicated¿ and that staff ¿cannot remember everything when they need to change a parameter or adjust pressure and/or weight.¿ hillrom representatives have performed and continue to offer support via onsite training sessions to resolve this issue.It is noted that on multiple occasions the customer has either postponed, canceled, or has not made the necessary preparations to allow staff availability for training.Hillrom representatives continue to work with the customer to optimize the staff¿s understanding of the bed, as well its functions.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.If use error were to recur, it would be unlikely to result in serious injury as preventative measures and therapy instructions are outlined in the ifu.If any additional relevant information is received, the additional relevant information will be submitted in a supplemental report.
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