MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/05/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the facility requests a swap of a rotoprone bed, as the attending nurse indicated that during the supine process, the bed could not be returned to the prone position.The device's screen would not allow to pass the check point shown on the screen and would not allow to pass the check point shown on the screen and would automatically go back to rotation screen.The nurse contacted the arjohuntleigh representative over a phone and in accordance to provide guidance tried to reboot the system, unfortunately it has not solved the issue.A new device has been delivered to the facility within an hour as a replacement.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4346609
• MDR Text Key: 20748762
• Report Number: 1419652-2014-00321
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other