MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Model Number 209500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

On (b)(6) 2014, the following was reported to arjohuntleigh complaints dept: arjohuntleigh account executive reported that on (b)(6) 2013, the customer alleged the unit experienced a computer control error which was resolved via clearing the error log.There was no injury.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

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.This report is being filed late due to lack of the arjohuntleigh employee not relaying the complaint to the arjohuntleigh complaints dept.The complaint process regarding field employees is being reviewed and will be addressed in a supplemental report.Add'l info will be provided upon conclusion of the manufacturer investigation.

• Brand Name: ROTOPRONE
• 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 rd; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3847700
• MDR Text Key: 4685574
• Report Number: 3010048749-2014-00048
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1