Patient was initially diagnosed with an unstageable pressure injury on (b)(6) 2024.The last assessment on (b)(6) 2024 classified the injury as a stage 3.The location of the injury is on the natal cleft.The reporting facility indicated they used a topical application and dressing to treat the pressure injury.The reporting facility indicated they do not believe the guardian device caused or contributed to the injury observed on the patient.Investigation of the available information from the guardian system noted 8 incidences where the using facility did not utilize the pause feature of the device for 12 consecutive hours, which can lead to enhancer migration.On (b)(6) 2024 therapy was paused and then resumed with the enhancer potentially mispositioned.This is based on a review of the guardian system event log information, noting "suspected patient misposition" events.The device continued to log several misposition events until the patient was discharged on (b)(6) 2024, resulting in 48 hours of less than optimal therapy.An update will be filed if any further relevant information becomes available.
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