MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. EVOLVE

Model Number PIQ-EV-DPV3584R

Device Problem Material Integrity Problem (2978)

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 supply chain manager: 12 evolve mattresses are developing a depressed area in the center of the mattresses.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 3 of 12 events for this facility.

Manufacturer Narrative

This report is being filed by the mfr arjohuntleigh, inc ((b)(4)).Please note that previous medwatch reports for this product may have been submitted from the mfr 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 info will be provided upon conclusion of the mfr investigation.

• Brand Name: EVOLVE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wet more rd ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd; ste 308; san antonio, TX 7824 ; 2103170412
• MDR Report Key: 3813328
• MDR Text Key: 4526836
• Report Number: 3010048749-2014-00038
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

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-DPV3584R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/28/2014
• 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