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

Catalog Number	297300000000
Medical Device Problem Codes	Positioning Problem (3009); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a pressure injury due to the mattress adjusting the patient's positioning/weight differently than the customer had set it to.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Further investigation identified that the reported issues were due to pump hoses coming detached from the mattress as well as the staff not setting the patient weight correctly.Based on available information, stryker determined that the pressure injury was not serious in nature.

• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23620837
• Report Number: 0001831750-2025-00744
• Device Sequence Number: 10072799
• Product Code: IKZ
• UDI-Device Identifier: 07613327523867
• UDI-Public: 07613327523867
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/29/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/29/2026
• 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