MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. EVOLVE

Model Number PIQ-EV-DPNB3584-N

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

On (b)(6) 2014, the following was reported by the arjohuntleigh account executive (ae): in (b)(6) 2013, 19 evolve mattresses were purchased by the facility for a new intensive care unit that would be opened on (b)(6) 2013.Presently all 19 mattresses are visibly depressed in the center.The patients that were on the mattresses were complaining that the depression in the mattresses made changing positions difficult as well as making the mattresses uncomfortable.When the ae inspected the mattresses, the helix pods were visibly compressed and low.If this malfunction were to recur, it may cause or contribute to serious injury or medical intervention to prevent harm.Therefore this malfunction is reportable.This complaint is number 2 of 19 complaints regarding the mattresses at this facility.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Add'l info will be provided upon conclusion of the manufacturer investigation.

• Brand Name: EVOLVE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3818465
• MDR Text Key: 4391431
• Report Number: 3010048749-2014-00019
• Device Sequence Number: 1
• Product Code: IKY
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIQ-EV-DPNB3584-N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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