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

Catalog Number	297300000000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Pressure Sore/Ulcer (2326)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient sustained a pressure injury.Attempts are being made to gather additional details from the user facility.
Additional Manufacturer Narrative
The device was not evaluated.This issue was resolved for the customer by starting 2 hours of automated body shifting and repositioning the patient to relieve the pressure.
Event or Problem Description
It was originally reported that a patient sustained a pressure injury.It was further reported that this was a rash and not a serious injury.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22636952
• Report Number: 0001831750-2025-00717
• Device Sequence Number: 9166406
• Product Code: IKZ
• UDI-Device Identifier: 07613327523867
• UDI-Public: 07613327523867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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 Catalogue Number: 297300000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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
• Patient Weight: 64 KG