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

Catalog Number	297300000000
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Disorders (4543)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received alleged skin issues while laying on the integrated mattress.Further information has not been provided.
Event or Problem Description
It was reported that the patient received marks on their back while laying on the integrated mattress.
Additional Manufacturer Narrative
It was reported that the patient received marks on their back while laying on the integrated mattress.The customer did not provide any further information regarding the need for treatment.The original product was incorrectly reported.The correct product identification has been corrected in section d4.

• 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: 18676932
• Report Number: 0001831750-2024-00306
• Device Sequence Number: 12297235
• 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): 06/26/2024
• 2 Devices were Involved in the Event: 1 2

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: 01/14/2024
• Supplement Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2022
• 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