MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the nurse.The rotoprone had a control error alarm on the screen and stopped rotating.The control error alarm began after the patient had been rotating for several hours in the prone position.The arjohuhtliegh clinical specialist verbally instructed the nurse to manually place the patient in the supine position, unplug the unit, re-set the battery switch which resolved the alarm.There was no injury reported.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.((b)(4)).Please note that 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 registration # (b)(4).Additional information will be provided upon conclusion of the manufacturer investigation.The submission of this report and related information does not necessarily reflect a conclusion by arjohuntleigh that the report or information is an acknowledgement that arjohuntleigh, arjohuntleigh employees or arjohuntleigh products caused or contributed to the reportable event.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd.; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, suite 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3930034
• MDR Text Key: 4598592
• Report Number: 3010048749-2014-00009
• 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: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• 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
• Date Manufacturer Received: 02/21/2014
• 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: Reuse
• Patient Sequence Number: 1