Model Number 297300000000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pressure Sores (2326)
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Event Date 03/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the customer had a patient experience minor pressure injuries on an isolibrium pe support surface, although not specific serial numbers were provided.A stryker representative checked all of the customer's isolibrium pe units and all were found to be operating correctly, likely indicating that the alleged injuries were the result of use error and not due to any failure of the stryker products.
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Manufacturer Narrative
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The customer provided the serial number of the unit after the initial mdr was submitted.B5 updated to reflect this.
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Event Description
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It was reported that the customer had a patient experience minor pressure injuries on an isolibrium pe support surface.A stryker representative checked all of the customer's isolibrium pe units and all were found to be operating correctly, likely indicating that the alleged injuries were the result of use error and not due to any failure of the stryker products.
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Search Alerts/Recalls
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