MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. EVOLVE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the nurse.It was noted that the mattresses were going flat in the center.There are 5 cases of skin breakdown (dates unk) due to the mattresses.Arjohuntleigh is reporting this with an abundance of caution as it is unknown the extent of the skin breakdown.This is report 5 of 5 that will be submitted.

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.Additional information 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 98247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore dr.; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3721221
• MDR Text Key: 4269280
• Report Number: 3010048749-2014-00016
• 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: 02/25/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/12/2014
• 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
• Patient Outcome(s): Other