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

Model Number	SSP18RBDDA
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.End-user was reclining in the chir on his patio.The back bar broke.He fell and hit his head.He sought medical attention.He had a bump on the back of his head.No cat scan or x-rays taken.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; #297 chuqiao road; zhenjiang city; jiangsu,, 21200 0; CH 212000
• MDR Report Key: 9583739
• Report Number: 2438477-2020-00002
• Device Sequence Number: 491895
• Product Code: IOR
• UDI-Device Identifier: 00822383232072
• UDI-Public: 822383232072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020
• Report Date (Section F): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SSP18RBDDA
• Device Catalogue Number: SSP18RBDDA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2019
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Weight: 76
• Date Report Sent to FDA: 01/13/2020