K-4oem AIRE-FLOAT K-4oemUHS88MS8ELRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817012022209), received between Jun 25, 2020 and Jul 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient Device Interaction Problem

  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 pa

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 50010845 ↗
• MalfunctionNov 16, 2020Smoking; Smoking

  NURSE NOTIFIED THE DISTRIBUTER OF THE DEVICE ON (B)(6) 2020 THAT THE MATTRESS STARTED SMOKING WHILE IN USE ON A PATIENT. THE BOTTOM OF THE MATTRESS WAS REPORTED TO BE HOT. THE PATIENT WAS NOT HARMED.

  Patient problems: Insufficient Information

  MAUDE report 10846640 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INCIDENT WAS REPORTED TO KAP MEDICAL BY (B)(6) ON (B)(4) 2020. THE REPORT STATES THAT THE RN ENTERED THE PATIENT ROOM AT APPROX. 2 AM AND FOUND THE PATIENT ON THE GROUND KNEELING NEXT TO THE BED. THE BED (UMANO MEDICAL OOK SNOW BARIATRIC BED 200-0000) EXIT ALARM WAS NOT SET BECAUSE THE RN STATED THAT SHE DID NOT KNOW HOW TO SET IT. IT IS UNKNOWN IF THE PATIENT FELL. THE EVENT OCCURED AT (B)(6) HOSPITAL CENTRAL IN (B)(6). THE MATTRESS WAS MANUFACTURED BY KAP MEDICAL FOR (B)(4). THE MATTRESS WAS A SKINGUARD XMS MATTRESS SYSTEM. THE BED WAS NOT MANUFACTURED BY KAP MEDICAL. THERE WERE NO INITIAL REPORTS THAT THE MATTRESS CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Fall

  MAUDE report 10197701 ↗