MAUDE Adverse Event Report: CHAMPION MFG. INC. 54 SERIES; STANDARD MEDICAL RECLINER

Model Number 547T09-73

Device Problem Device Tipped Over (2589)

Patient Problem Skin Tears (2516)

Event Date 10/18/2015

Event Type  malfunction  

Event Description

This was an unobserved fall.Patient found face down on the floor with recliner on top of him.Patient had a skin tear on his head.A ct scan was done.Medical treatment consisted of cleaning the tear and wrapping with gauze.Unknown if the patient was in the chair at the time that he fell or if he fell and tried to right himself after falling by pulling on the chair.

• Brand Name: 54 SERIES
• Type of Device: STANDARD MEDICAL RECLINER
• Manufacturer (Section D): CHAMPION MFG. INC.; 2601 industrial pkwy.; elkhart IN 46516
• Manufacturer Contact: matthew copeland ; 2601 industrial pkwy.; elkhart, IN 46516 ; 8009985018
• MDR Report Key: 5260905
• MDR Text Key: 32762191
• Report Number: 1834066-2015-00002
• Device Sequence Number: 1
• Product Code: FRJ
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 547T09-73
• Device Catalogue Number: 547T09-73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 98