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

Model Number SKNGUARD88MSEL

Device Problem Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

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 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
• Type of Device: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881 3373
• Manufacturer (Section G): KAP MEDICAL; 1395 pico street; corona CA 92881 3373
• Manufacturer Contact: kevin foran ; 1395 pico street; corona, CA 92881-3373 ; 9513404360
• MDR Report Key: 10846640
• MDR Text Key: 216552558
• Report Number: 3003083675-2020-00401
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00817012022209
• UDI-Public: 00817012022209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SKNGUARD88MSEL
• Device Catalogue Number: 303695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOSPITAL BED.
• Patient Outcome(s): Required Intervention