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

Model Number	SKNGUARD88MS8EL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is manufactured by kap medical for (b)(4).The adverse event was reported to kap medical by (b)(4) on (b)(6) 2020.There is no indication of device malfunction at this time.The device (mattress system) was on the patient's bed at the time of the event.Since it was reported that the patient may have sustained injury, this report was submitted out of caution.The bed that was used was not manufatured or sold by kap medical.
Event or Problem Description
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.

• Brand Name: SKINGUARD MATTRESS SYSTEM
• Common Device Name: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st.; corona, ca
• MDR Report Key: 10197701
• Report Number: 3003083675-2020-00137
• Device Sequence Number: 11000066
• Product Code: FNM
• UDI-Device Identifier: 00817012022209
• UDI-Public: (01)00817012022209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: SKNGUARD88MS8EL
• Device Catalogue Number: 303695
• Device Lot Number: 200000374
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR