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

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

Patient attempted to put footrest of reclining chair down and reach for his call bell.The chair tipped forward and the patient slid to the floor off of the recliner.

• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): CHAMPION MANUFACTURING INC.; 2601 industrial pkwy.; elkhart IN 46516
• MDR Report Key: 6830511
• MDR Text Key: 83984771
• Report Number: 6830511
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109