MAUDE Adverse Event Report: KAP MEDICAL SKINGUARD; THERAPEUTIC SUPPORT SURFACE

Model Number	SKNGUARD88MSEL
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident was reported to kap medical by (b)(6) health corporate office.Minimal information provided.The system consists of a mattress and a control unit.The control unit is designed to attach to the foot of the bed and the mattress is connected to the control unit by a manifold that distributes air to the mattress.There are no electrical components in or on the mattress, so the likelihood of a fire on or in the mattress is very low due to the segregation from the control unit.An external source of combustion must be introduced.The mattress is cal 117 fire rated.Kap medical has requested the return of the device from (b)(6) health for investigation and repair if required.
Event or Problem Description
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.

• Brand Name: SKINGUARD
• Common Device Name: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881 3373
• MDR Report Key: 10846640
• Report Number: 3003083675-2020-00401
• Device Sequence Number: 4282533
• Product Code: FNM
• UDI-Device Identifier: 00817012022209
• UDI-Public: 00817012022209
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace,Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SKNGUARD88MSEL
• Device Catalogue Number: 303695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOSPITAL BED.
• Outcome Attributed to Adverse Event: Required Intervention