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

Model Number SKINGUARDFLOATMS8

Device Problem Deflation Problem (1149)

Patient Problem Tissue Breakdown (2681)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

The owner of the device, (b)(6), sent a complaint on 11/20/2020, that a mattress deflated, and caused deep tissue pressure injury to the patient.Kap medical requested the device be returned for evaluation.The mattress is designed with a safety air cushion in the event of deflation.This keeps the patient from bottoming out.Additionally, the unit is designed with a visual and audible alarm that will flash and beep when the mattress senses low inflation.The injury was reported to (b)(6) on (b)(6) 2020.Kap medical received the complaint on 11/20/2020.

Event Description

Per report received from (b)(6) on (b)(6) 2020, the facility discovered the mattress supporting the patient deflated.The control unit showed a low pressure warning and alarm.The nurse reports the patient developed deep tissue wound on the buttocks as a result of the deflation.

• Brand Name: SKINGUARD FLOAT
• Type of Device: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881 3373
• MDR Report Key: 10891827
• MDR Text Key: 217919674
• Report Number: 3003083675-2020-00408
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00817012021899
• UDI-Public: (01)00817012021899
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/23/2020

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
• Device Operator: Health Professional
• Device Model Number: SKINGUARDFLOATMS8
• Device Catalogue Number: 303713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other