MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 IN,PREMIUM END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	2872
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while lying on the mattress, the patient experienced skin break down leading to a deep tissue injury.The user facility reported the injury was treated with pressure relieving interventions, moisture management, regular skin assessments, and daily mist therapy.Attempts have been made to gather additional information from the user facility but stryker has not received a response back at this time.
Event or Problem Description
It was reported that a patient sustained a pressure injury while using the isotour surface in the icu.The user facility stated that all turning and injury prevention protocols were followed; however, due to the patient's skin condition and braden scores they were at risk for developing a pressure injury before being placed on the isotour surface.There are a number of different factors that contribute to pressure injuries, such as nutrition, skin condition, moisture and pressure injury treatment protocol.Given that all factors that are within stryker¿s control were evaluated and found to be operating as intended, it was determined that there were no defects found with the isotour surface that would have potentially caused or contributed to the alleged pressure injuries.
Additional Manufacturer Narrative
The device evaluation has been completed and section h codes have been updated to reflect this.Additional information regarding the alleged injury has been provided by the user facility and updated under section b5.

• Brand Name: ISOTOUR, 84 IN,PREMIUM END406
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11961913
• Report Number: 0001831750-2021-00946
• Device Sequence Number: 4247095
• Product Code: FNM
• UDI-Device Identifier: 07613327424607
• UDI-Public: 07613327424607
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 08/25/2021

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
• Operator of Device: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability