MAUDE Adverse Event Report: KAP Medical K-4oem Skinguard; Therapeutic Support Surface Mattress

Model Number	K-4oem
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On july 16, 2026, agiliti health, inc.Notified kap medical of a potential injury involving an agiliti skinguard low air loss mattress system manufactured by kap medical.On the same day, (b)(6) 2026, kap medical contacted personnel at uc san diego health to obtain additional information regarding the reported event.According to information provided by uc san diego health, the patient developed acute onset back pain on (b)(6) 2026.The patient's symptoms subsequently worsened, and a computed tomography (ct) scan performed on (b)(6) 2026 identified an acute t10 vertebral compression fracture.Following identification of the fracture, the patient's spouse reported that while the patient was seated on the edge of a hospital bed equipped with an agiliti skinguard low air loss mattress system, she heard what she described as a "popping" sound from the mattress and believed the mattress may have contributed to the patient's injury.This information was reported by the patient's spouse and was not witnessed by hospital staff.Uc san diego health or agiliti health, inc.Have not verified the circumstances of the event as described.The treating physician discussed with the family that the patient's underlying medical condition may have increased the patient's susceptibility to osteoporosis and compression fractures.This discussion was related to the patient's clinical condition and potential risk factors and does not represent a determination of the cause of the fracture.After the spouse's concerns were reported, the skinguard low air loss mattress system was removed from service and evaluated by agiliti.According to the inspection report, both the mattress and blower were found to be operating as intended.No defects, malfunctions, failures, or abnormalities were identified during the evaluation.At this time, the investigation has not identified any device malfunction or failure.Based on the information currently available, there is no evidence that the mattress system contributed to the reported injury.
Additional Manufacturer Narrative
On 7/21/2026, kap medical contacted agiliti helath to return the mattress for investigation.An internal investigation, including device testing, will be performed by kap medical.

• Brand Name: K-4oem Skinguard
• Common Device Name: Therapeutic Support Surface Mattress
• Manufacturer (Section D): KAP Medical; 1395 pico street; corona CA 92883
• Manufacturer (Section G): KAP Medical; 1395 pico street; corona 92881
• Manufacturer Contact: kevin foran ; 1395 pico street; corona, CA 92881 ; +1(951)340-4360
• MDR Report Key: 50010845
• Report Number: 3003083675-2026-00001
• Device Sequence Number: 12247250
• Product Code: FNM
• UDI-Device Identifier: 00817012022209
• UDI-Public: 00817012022209
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 510K Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: Health Professional
• Device Model Number: K-4oem
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male