MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM PE SUPPORT SURFACE; BED, PATIENT ROTATION, POWERED

Model Number	297300000000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hyperemia (1904); Insufficient Information (4580)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that a nurse went to turn a patient and 3 circle patterns were noted on the left thigh.Further information was not reported.
Additional Manufacturer Narrative
Four surfaces were returned for further evaluation, and the surface involved in the alleged event was not among the four surfaces, the specific surface involved in this alleged event could not be determined.A senior staff engineer evaluated the returned surfaces and determined that the impressions on the skin were likely caused by over inflated air pods.The surface involved in this event was alleged to have had the same issue as the evaluated surfaces.Therefore, based on the analysis of the evaluated surfaces, a quality assurance engineer determined the alleged over inflated pods was not due to any component level malfunction.The event was likely caused by the customer not zeroing the scale on the associated bed between patients leading to the incorrect inflation level of the surface.A principal medical science liaison was consulted who determined that based on analysis of data provided, the patient experienced reactive hyperemia from the gel.The injury was identified to be a minor injury as no treatment was required.This issue was resolved for the customer by the sales account manager providing additional education to the staff regarding zeroing the scale on the associated beds between patients.
Event or Problem Description
It is reported that a nurse went to turn a patient and 3 circle patterns were noted on the left thigh.

• Brand Name: ISOLIBRIUM PE SUPPORT SURFACE
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17219626
• Report Number: 0001831750-2023-00675
• Device Sequence Number: 15008632
• Product Code: IKZ
• UDI-Device Identifier: 07613327523867
• UDI-Public: 07613327523867
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 297300000000
• Device Catalogue Number: 297300000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown