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

Model Number 2872

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problems Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

It was reported that patients are experiencing skin break down while using the isotour surfaces in the icu.No further information has been provided at this time regarding the severity or treatment of the skin breakdown.

Manufacturer Narrative

It was originally reported that the user facility had a general complaint regarding an increase in patient skin breakdown.Upon further communication, the user facility clarified that this is not a general complaint and provided specific instances of pressure injuries.Additional mdrs will be filed to capture the specific instances of pressure injuries.Section b5 has been updated to reflect the corrected information provided by the customer.

Event Description

It was reported that a patient sustained a pressure injury while using the isotour surface in the icu.Additional information regarding the pressure injury has been requested from the user facility.

Event 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 covid-19 as well as the patient's 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.

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
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11922981
• MDR Text Key: 253865403
• Report Number: 0001831750-2021-00926
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327424607
• UDI-Public: 07613327424607
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

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
• Device Operator: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 05/07/2021; 05/07/2021
• Supplement Dates FDA Received: 06/08/2021; 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other