MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC ROTOPRONE

Model Number 209500

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 03/27/2014

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the touch screen on the rotoprone froze and would not accept commands.There was no pt injury.The bed was able to be manually rotated as needed until the pt was transferred to a new bed.

Manufacturer Narrative

This report is being filed by the manufacturer arjhuntleigh, inc.(registration #(b)(4)).Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, in (under registration #(b)(4)).As of (b)(4)2012, complaints related to this product are to be handled by arjohuntleigh, inc.And registration #(b)(4).Additional information 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; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3820624
• MDR Text Key: 19486467
• Report Number: 3010048749-2014-00049
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2014

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: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/11/2014
• 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