MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Model Number 209500

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the arjohuntleigh representative: on (b)(6) 2014, the bed was alarming "buckle or hatch open".There was no injury associated with this event.This is being reported with an abundance of caution as if this type of event were to recur it may cause or contribute to death, serious injury or medical intervention to prevent harm.It is unknown if the bed malfunctioned.When the investigation along with the device evaluation is completed, a supplemental report will be submitted.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.((b)(4)).Please note the previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.((b)(4)).As of november 2012, complaints related to this product are to be handled by arjohuntleigh, inc.And registration # (b)(4).Add'l info will be provided upon conclusion of the manufacturer investigation.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3915534
• MDR Text Key: 4667706
• Report Number: 3010048749-2014-00008
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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?: No
• Date Manufacturer Received: 02/14/2014
• 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: Reuse
• Patient Sequence Number: 1