STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 IN,PREMIUM END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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Model Number 2872 |
Device Problems
Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
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Patient Problems
Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2020 |
Event Type
malfunction
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Event Description
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It was reported that while lying on the mattress, the patient experienced skin break down leading to a deep tissue injury.The user facility reported the injury was treated with pressure relieving interventions, moisture management, regular skin assessments, and daily mist therapy.Attempts have been made to gather additional information from the user facility but stryker has not received a response back at this time.
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Event Description
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It was reported that a patient sustained a pressure injury while using the isotour surface in the icu.The user facility stated that all turning and injury prevention protocols were followed; however, due to the patient's skin condition and braden scores they were at risk for developing a pressure injury before being placed on the isotour surface.There are a number of different factors that contribute to pressure injuries, such as nutrition, skin condition, moisture and pressure injury treatment protocol.Given that all factors that are within stryker¿s control were evaluated and found to be operating as intended, it was determined that there were no defects found with the isotour surface that would have potentially caused or contributed to the alleged pressure injuries.
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Manufacturer Narrative
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The device evaluation has been completed and section h codes have been updated to reflect this.Additional information regarding the alleged injury has been provided by the user facility and updated under section b5.
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Search Alerts/Recalls
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