MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. EVOLVE

Device Problems Deflation Problem (1149); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2014, the following was reported to arjohuntleigh: there are two evolve mattresses that appear to have a deflated area.There were no injuries associated with this complaint.If this type of malfunction were to recur, it may cause or contribute to serious injury or medical intervention to prevent harm.Therefore, this event is reportable.This is number one of two complaints for this malfunction from this facility.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.((b)(4)).Previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.((b)(4)).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.And (b)(4).Additional information will be provided upon conclusion of the manufacturer investigation.

• Brand Name: EVOLVE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3820949
• MDR Text Key: 4398652
• Report Number: 3010048749-2014-00051
• 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: 03/26/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/15/2014
• 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