MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. EVOLVE

Model Number KEV-DPNB-3584

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

On (b)(6) 2014, the following was reported to arjohuntleigh by the facility: there were a total of 20 mattresses that were returned due to deformation in the mid-section.This is complaint number 3of 20.There was no injury associated with this complaint.This is being reported with an abundance of caution as if this type of malfunction were to recur, it may cause or contribute to death, serious injury or medical intervention to prevent harm.

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(6) 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 road; ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 12625 wetmore road; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3900210
• MDR Text Key: 17615768
• Report Number: 3010048749-2014-00057
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2014

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: KEV-DPNB-3584
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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