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

Catalog Number	2872000012
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an increase in unspecified pressure injuries.Specific numbers, severity of injury, and treatment details have not been provided at the time of reporting.
Additional Manufacturer Narrative
The imdrf codes have been updated to reflect the completed investigation.
Event or Problem Description
It was reported that there was an increase in unspecified pressure injuries.Specific numbers, severity of injury, and treatment details have not been provided at the time of reporting.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: 20369659
• Report Number: 0001831750-2024-01076
• Device Sequence Number: 11734960
• Product Code: FNM
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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 Catalogue Number: 2872000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/26/2025
• 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