MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS)9 DRIVE; TRANSPORT CHAIR

Model Number	TR18
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a transport chair.Our claims department is awaiting data regarding the device and the incident.We have not received the device for evaluation.We are filing this report in an overabundance of caution.The device reportedly fell apart while in use.The user was injured.Based on the serial number the device was approximately four (4) years old.

• Brand Name: DRIVE
• Common Device Name: TRANSPORT CHAIR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS)9; no. 2 workshop; 3 shenghui soutth rd; nantou town, ; CH
• MDR Report Key: 9033980
• Report Number: 2438477-2019-00063
• Device Sequence Number: 14058495
• Product Code: INM
• UDI-Device Identifier: 00822383121499
• UDI-Public: 822383121499
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019
• Report Date (Section F): 09/13/2019

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: TR18
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 5 YR
• Date Report to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/13/2019