MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number CX418ADDA-SF

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 11/04/2016

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified by a claims representative of an incident involving a wheelchair that is imported and distributed by drive.The end user was attempting to move from the bed to the wheelchair when the arm rest fell off, causing the patient to fall and fracture his femur.The patient underwent surgery and was hospitalized for 4 days.

• Brand Name: DRIVE
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; 2 th nanwei road; zhenjiang jiangsu, cn-32 21200 0; CH 212000
• MDR Report Key: 6208910
• MDR Text Key: 63407877
• Report Number: 2438477-2016-00065
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• 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: 12/28/2016,11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CX418ADDA-SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2016
• Distributor Facility Aware Date: 11/28/2016
• Date Report to Manufacturer: 12/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization