MAUDE Adverse Event Report: CHAMPION MANUFACTURING INC.; CHAIR AND TABLE, MEDICAL

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

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

Event Date 07/28/2011

Event Type  malfunction  

Event Description

Patient states that the reclining chair he was sleeping in did not go back into sitting position so he could get out of chair to use the commode.The patient states he slid himself forward when the footrest of the chair tipped forward.

• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): CHAMPION MANUFACTURING INC.; 2601 industrial pkwy.; elkhart IN 46516
• MDR Report Key: 6830575
• MDR Text Key: 83984221
• Report Number: 6830575
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 173