MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. RIK

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

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc.From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment.When reviewing similar reportable events for rik device range, we have not been able to find any similar fault description compared to the situation investigated here: overlay being placed directly on the bed's mattress platform, which further lead to patient injury.There is no trend observed for reportable complaints with this failure for rik family.Based on the information collected to date and the device evaluation conducted by an arjohuntleigh representative, we have been able to establish that the overlay was in a good working condition - no discrepancies were found on the device which could cause with this kind of injury.Unfortunately, in the complaint at hand, the customer has been wrongly informed by one of the arjohuntleigh employees that the rik fluid overlay may be placed directly on the bed's frame as the foam underneath the fluid pads is sufficient enough for that purpose.The misleading information was given that this mattress is not an overlay.This situation resulted with rik fluid overlay being placed directly on the bed frame.As a result, patient who started using the device developed pressure ulcers (2-3 grade).It was confirmed that the arjohuntleigh employee had a training, back in the january 2013, from the pressure relieve mattresses, where it was clearly stated that the overlay mattresses have to be placed onto the other foam mattress, not on the bed frame directly.Nevertheless and having in mind the occurred situation, the training is to be repeated.Additionally, the product instruction for use (e.G.P/n 201875 rev.B) has not been delivered to the facility together with the device.Mentioned product labeling includes in several places the information that the device is an overlay and needs to be placed on top of another mattress: the rik fluid overlay has been designed to provide a high degree of pressure redistribution, low shear, comfort and stability.One of the device features is that it attached easily to most hospital mattresses.One of the step of the rik fluid overlay assembly is: lay out the bottom panel over the bed mattress with the end labelled head at the appropriate end it has been clarified, that the product's instruction for use was not delivered with the device as a result of the one-off, human error - this step in the device delivery process was omit.Therefore the quality control checklist used at the rental fleet for this device would be updated in order to double check and assure that the product labeling would be delivered always with the device.In summary, the device was being used when the event occurred, therefore it played a role in the event.No failure has been found within the device.However, the device was delivered to the facility without product instruction for use and incorrect information about installation of the device were shared with the facility staff- it seems that these issues were direct contributory factors which lead to the event.Given the circumstances and the number of similar events, this incident appears to be an isolated one.We shall continue to monitor for any further events of this nature and do not purpose any further action at this time.

Event Description

(b)(4).

• Brand Name: RIK
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 5015800
• MDR Text Key: 25494170
• Report Number: 3007420694-2015-00157
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection

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?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No Information
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1