MAUDE Adverse Event Report: KOYA MEDICAL DAYSPRING; NON PNEUMATIC ACTIVE COMPRESSION DEVICE

Model Number	F-0050-02
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Impaired Healing (2378); Peripheral Edema (4578)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
What happened? a dayspring user experienced swelling.When did it occur? the user received the device on (b)(6) 2025.The user was trained by sales rep on (b)(6) 2026.The user's wound care nurse reported the swelling to koya on 14 apr 2026.How many parts were involved? two f-0050-02 lower leg garments, serial numbers: (b)(6).Who found the problem? the user's wound care nurse found the problem.Koya sales rep gathered additional information when they met with the user.Where did it happen? in the user's home.How often has it occurred? this is the first occurrence of this issue.The user reported using the device upside down "for the last 60 days", which was an approximation, as it was later clarified he had been using the device upside down since he started using the device in january.Additional information: the sales rep trained the user on (b)(6) 2026 in person.The sales rep himself was re-certified to dayspring & disease-state competency on 24 nov 2025.Based on available information, the device met all specifications.There is no evidence of malfunction of the device, and the attached packing slip indicates the required labeling was included with the device shipment.The device was being used for treatment, not diagnosis, at the time of the event.Based on available information, it appears misuse of the device could have contributed to the swelling experienced by the user.Following the report on 14 apr 2026, the user was provided with (1) retraining in person (2) additional accessories to adjust the fit of the device and (3) periodic status checks to monitor his condition.The sales and customer care teams were made aware of the issue for continuous improvement.The relevant dfmea was reviewed and updated to ensure all risks are captured appropriately.Following the initial visit to the user, the sales rep made two more visits between on (b)(6) 2026.During these visits the rep replaced the straps with longer straps, followed up to ensure correct use of the device, and gathered information on the user's condition.On (b)(6) 2026, the rep reported "i just met with [the user].I got him all set up with his straps.His right foot has gone down a little bit.He just got released from wound care yesterday.He is no longer needing to go to get his legs wrapped.".
Event or Problem Description
A nurse from a healthcare facility called koya medical sales rep stating that a dayspring user's feet were swollen.Sales rep went to the user's home and asked the user to demonstrate how he uses the dayspring device.It was discovered that the user has been putting the device on upside down since january 2026.The user's feet were now too big to fit into a foot wrap or the socks provided with the dayspring kit.His legs were wrapped from wound care and he wore compression wraps over the wound care wraps.The sales rep noted the user had two wounds, one on each leg.

• Brand Name: DAYSPRING
• Common Device Name: NON PNEUMATIC ACTIVE COMPRESSION DEVICE
• Manufacturer (Section D): KOYA MEDICAL; 2332 valdina st; dallas TX 75207
• Manufacturer (Section G): KOYA MEDICAL; 2332 valdina st; dallas TX 75207
• Manufacturer Contact: tori hallahan ; 2332 valdina st; dallas, TX 75207 ; 8339995692
• MDR Report Key: 25151314
• Report Number: 3033981998-2026-00001
• Device Sequence Number: 9397182
• Product Code: JOW
• UDI-Device Identifier: 00850012532736
• UDI-Public: (01)00850012532736(10)1705:001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: F-0050-02
• Device Catalogue Number: F-0050-02
• Device Lot Number: 1705:001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White