MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. RIK

Model Number VL2200E

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problem Pressure Sores (2326)

Event Date 06/18/2015

Event Type  Injury  

Event Description

Initially, it has been claimed that the patient developed 2-3 grade of pressure ulcers while using the device (noted at 7:30 pm).The patient was (b)(6) female.The patient had no pressure ulcers when submitted to the hospital on (b)(6) 2015 (12:30 pm).Additionally, it has been clarified that: as part of a trial, a rik fluid overlay was put into use on (b)(6) 2015 with a patient at 12:30pm.An arjohuntleigh employee provided instructions to the facility staff prior to use of the mattress.It was stated that the mattress can be placed onto the bed frame directly and that the foam underneath the fluid pads is sufficient enough for that purpose.The instructor accented, that this mattress reduces shearing forces and therefore it can be used for patients with high decubitus risk.It was also stated that the delivered device is not an overlay.The rik fluid overlay was placed directly on the bed's frame - which is against its intended use.

• Brand Name: RIK
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 1684
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 5015810
• MDR Text Key: 23538140
• Report Number: 1419652-2015-00254
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: VL2200E
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR