STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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Catalog Number 2872000012 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Pressure Sores (2326)
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Event Date 11/09/2023 |
Event Type
Injury
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Event Description
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It was reported that, while using the surface, the patient complained of pain in their sacral area.It was discovered that the surfaces gel had separated, and the patient was sitting on the frame of the mattress.The patient sustained a new stage 2 pressure injury.Attempts are being made to gather additional details from the user facility.
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Event Description
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It was reported that, while using the surface, the patient complained of pain in their sacral area.It was discovered that the surfaces gel had separated, and the patient was sitting on the frame of the mattress.The patient sustained a new stage 2 pressure injury.
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Manufacturer Narrative
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This event was previously evaluated through an internal investigation of the failure mode and found to not pose any additional risk to the patient.From this information, a stryker quality assurance engineer determined that the stage 2 pressure injury resulting from uneven pressure distribution was likely not due to any component level malfunction as the gel issue alleged.This issue was resolved for the customer by replacing the surface.
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Search Alerts/Recalls
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