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

Model Number	297300000000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The customer provided the serial number of the unit after the initial mdr was submitted.B5 updated to reflect this.
Event or Problem Description
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.

• 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: 16636513
• Report Number: 0001831750-2023-00321
• Device Sequence Number: 17931923
• 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): 08/03/2023

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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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