MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY COMPANY L DRIVE; OXYGEN CART

Model Number	13002SV-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is an oxygen cart.The device has not been returned for evaluation.The wheel on the e-cylinder broke.The cart fell causing a cut on the patient's ankle.The device is 6 years old.

• Brand Name: DRIVE
• Common Device Name: OXYGEN CART
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY COMPANY L; yunyang industrial park; danyang city; jiangsu, jiangsu, 21230 0; CH 212300
• MDR Report Key: 10418185
• Report Number: 2438477-2020-00039
• Device Sequence Number: 19801475
• Product Code: BZN
• UDI-Device Identifier: 00822383218403
• UDI-Public: 822383218403
• Combination Product (Y/N): N
• 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): 08/17/2020
• Report Date (Section F): 08/17/2020

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: No Information
• Device Model Number: 13002SV-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2020
• Device Age: 6 YR
• Date Report to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2020
• 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
• Date Report Sent to FDA: 08/17/2020