MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOAIR DOM 84 IN TYPE B PLUG; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number	2941000001
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient sustained a 1 stage 2 coccyx pressure injury.Attempts are being made to gather additional details from the user facility.
Additional Manufacturer Narrative
Further investigation identified that the reported issues were due to the power cord not being secured well (resulting in power loss to the pump), and a broken controller.Based on available information, stryker determined that the pressure injury was not serious in nature.
Event or Problem Description
No new information.

• Brand Name: ISOAIR DOM 84 IN TYPE B PLUG
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 24705739
• Report Number: 0001831750-2026-00026
• Device Sequence Number: 10556878
• Product Code: FNM
• UDI-Device Identifier: 07613327504002
• UDI-Public: 07613327504002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/18/2026

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: 2941000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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