MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRMEDSURG

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 01/23/2015

Event Type  No Answer Provided  

Event Description

It has been claimed by the customer that the pt was found on the floor.In accordance to the pt, he rolled on to his right side causing the bed rail to bend and gave out.Subsequently the pt fell through the crack between the side rail.No injuries have been reported.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• 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: 4536767
• MDR Text Key: 15896449
• Report Number: 1419652-2015-00050
• Device Sequence Number: 1
• Product Code: INX
• 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: 02/11/2015,01/23/2015

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Date Report to Manufacturer: 02/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1