MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	2860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained an unstageable pressure injury while on a stryker surface.Attempts are being made to gather additional details from the user facility.
Event or Problem Description
It was reported that a patient sustained an unstageable pressure injury while on a stryker surface.
Additional Manufacturer Narrative
The surface was returned to our facility for a visual and functional inspection.It was found that a patient received a hapi (unstageable) and this was not due to any component level defect of the product.A quality failure investigator performed a gel compression set test as outlined in the operations/maintenance manual and found the gel to be within specification.There are many factors that contribute to pressure ulcer development including heat, moisture, pressure braden scale ratings, patient mobility, nursing monitoring, and rotation schedules.Based on the information provided there was no defect or malfunction with the surface that would have caused or contributed to the pressure injury.
Event or Problem Description
It was reported that a patient sustained an unstageable pressure injury while on a stryker surface.

• Brand Name: ISOFLEX LAL 84IN W OPTION CVR
• Common Device Name: MATTRESS, FLOTATION THERAPY, NON-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 millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13688635
• Report Number: 0001831750-2022-00264
• Device Sequence Number: 19318660
• Product Code: IKY
• UDI-Device Identifier: 07613327278507
• UDI-Public: 07613327278507
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/14/2023

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?: No
• Device Model Number: 2860
• Device Catalogue Number: 2860000019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022; 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/20/2022; 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2017
• 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: Disability; Other
• Patient Sex: Unknown