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

Model Number SKINGUARD XMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2020

Event Type  Injury  

Manufacturer Narrative

The mattress is manufactured by kap medical for agiliti health.The adverse event was reported to kap medical by agiliti health on 06/10/2020.Limited information regarding patient information was received.There is no indication of device malfunction at this time.The mattress was on the patient's bed at the time of the event.Since it was reported that the patient may have sustained an injury, this report was submitted out of caution.The bed that was used in conjunction with the mattress is not manufactured or sold by kap medical.The patient was reported to have fallen from the bed.

Event Description

Rn requested a bariatric bed for a nonbariatric patient because the rn felt the patient needed more room.The patient reportedly fell out of the bed.The bed was not manufactured by kap medical.The mattress was an agiliti skinguard xm mattress, manufactured by kap medical.There is no indication at this time that the mattress contributed to this event.This report is being filed in caution due to the mattress being present on the bed at the time of the event.

• Brand Name: SKINGUARD XM MATTRESS SYSTEM
• Type of Device: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st.; corona, ca
• Manufacturer (Section G): KAP MEDICAL; 1395 pico st.; corona, ca
• Manufacturer Contact: kevin foran ; 1395 pico st.; corona, ca ; 3404360265
• MDR Report Key: 10202493
• MDR Text Key: 198315349
• Report Number: 3003083675-2020-00162
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SKINGUARD XMS
• Device Catalogue Number: 303920
• Device Lot Number: 170002469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR