MAUDE Adverse Event Report: Agiliti Health - Ellis RAYE'S, Inc dba Sizewise Manufacturing; Adapt Pump

Model Number	61600200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that pump was alarming as if there was a pressure issue, and the mattress was rock hard.The nurse stated that the patient's wound had worsened and she could now put her fist in it.The initial cause of the wound was not disclosed.
Additional Manufacturer Narrative
Device is in our possession and testing is underway per (b)(4).

• Brand Name: RAYE'S, Inc dba Sizewise Manufacturing
• Common Device Name: Adapt Pump
• Manufacturer (Section D): Agiliti Health - Ellis; 204 w 2nd st; ellis KS 67637
• Manufacturer (Section G): Agiliti Health - Ellis; 204 w 2nd st; ellis KS 67637
• Manufacturer Contact: bethany schultz ; 204 w 2nd st; ellis, KS 67637 ; +1(507)261-5682
• MDR Report Key: 50060957
• Report Number: 1954156-2026-00006
• Device Sequence Number: 10665817
• Product Code: FNM
• UDI-Device Identifier: 00845699045914
• UDI-Public: 00845699045914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: No
• Device Model Number: 61600200
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2026
• 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: Adapt Air Mattress SN: (b)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown