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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	11/30/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported through a clinical survey that a 67-year-old, underweight, female patient was emergently admitted to the intensive care unit with ¿sepsis from pressure ulcers.¿ the patient presented with a braden score of 11 and 4 pressure injuries at the onset of treatment.One stage 3 and one stage 4 for pressure injury involving the heel area.Additionally, the patient presented with two unstageable pressure injuries involving the sacral and trochanteric areas.During the treatment period, the two pressure injuries involving the heels improved by 40% reduction in volume.However, two new stage 2 presenting in the elbow area, reportedly contributing to a deterioration in the patient¿s health, resulting in prolonged hospitalization and ultimately, death.The survey respondent noted that there was no device malfunction, and the product was being used in accordance with the indications for use.Several comorbid conditions and medications are noted which may impede wound healing.Given the previous information and the multi-factorial nature of pressure injury development it cannot be conclusively determined that the product had a causal relationship or contribution to the patient¿s outcome.Nonetheless, we are choosing to file this event out of an abundance of caution.No additional information was provided.Additional attempts are being made to obtain more information.
Additional Manufacturer Narrative
Multiple attempts have been made to gather further information, with no response received.
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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21326830
• Report Number: 0001831750-2025-00329
• Device Sequence Number: 18174790
• Product Code: FNM
• UDI-Device Identifier: 07613327504002
• UDI-Public: 07613327504002
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/10/2025

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?: No
• Device Catalogue Number: 2941000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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: Death
• Patient Sex: Unknown