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

Model Number SKNGUARD88MS8EL

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

Patient Problem Fall (1848)

Event Date 05/26/2020

Event Type  Injury  

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 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
• 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: 10197701
• MDR Text Key: 196668861
• Report Number: 3003083675-2020-00137
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00817012022209
• UDI-Public: (01)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: Inspection
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SKNGUARD88MS8EL
• Device Catalogue Number: 303695
• Device Lot Number: 200000374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR