MAUDE Adverse Event Report: AGILITI HEALTH - CORONA RAYE'S, INC DBA SIZEWISE MANUFACTURING; IMMERSE MATTRESS FAMILY

Model Number	27400359
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Agiliti aware date was 3/4/2025, but employee that was notified failed to submit complaint until (b)(6) 2025.A capa was opened to address process breakdown.Testing has not yet been completed.An updated mdr will be sent upon testing completion.
Event or Problem Description
Patient presented with breakdown on buttocks upon admission and with treatment and the immerse support surface the skin was healing.After several days of being on the surface, staff requested patient be moved to regular icu surface as the "surface unit was becoming very hot".Patient's back region was becoming more reddened, and she had a spiked temp as well.When they moved her to a regular icu surface, they reported patient's temp went down 2 degrees.Two days after being placed on regular icu surface, patient's buttocks appeared very dark and purple in discoloration.
Additional Manufacturer Narrative
Testing: on 7/30/2025 testing started on the support surface and blower.The ambient room temperature was at 71.3 degrees f, and the support surface temperature was 72.6 degrees f.Turned blower on, set to autofirm, and left it on running for 2 hours.At this time, we did another surface temperature check, and the support surface tested at 72.5 degrees f.Left the unit running until 7/31/2025 at 11:00 am, so the unit ran for about 22.5 hours.We then took another ambient air temp reading which was 71.3 degrees f, and the support surface temperature was at 77.7 degrees f.From this testing the unit did go up about 5 degrees.Support surface was checked for any warm spots and there were none.After running the blower for the 22.5 hour test, the external case temperature was at 77.8 degrees.Conclusion: the test was conducted under the conditions that represented worst case conditions.The autofirm setting represents the maximum blower setting but would not be used while a patient was on the surface for an extended period of time.The overall change of 5 degrees f represents normal function of the device, and the resulting temperature would not cause any patient harm.Additionally, the device was tested and found to be in proper operating condition.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: IMMERSE MATTRESS FAMILY
• Manufacturer (Section D): AGILITI HEALTH - CORONA; 252 mariah cir.; corona CA 92879
• Manufacturer (Section G): AGILITI HEALTH - CORONA; 252 mariah cir.; corona CA 92879
• Manufacturer Contact: kari brower ; 252 mariah cir.; corona, CA 92879
• MDR Report Key: 22116624
• Report Number: 2030732-2025-00008
• Device Sequence Number: 15191302
• Product Code: FNM
• UDI-Device Identifier: 00845699004393
• UDI-Public: 00845699004393
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Model Number: 27400359
• Device Lot Number: 0037579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMMERSE BLOWER REV 3 - 00845699003457, SN (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female