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

Model Number 13002SV-1

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 06/03/2020

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 203298666
• Report Number: 2438477-2020-00039
• Device Sequence Number: 1
• Product Code: BZN
• UDI-Device Identifier: 00822383218403
• UDI-Public: 822383218403
• 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: 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
• Device Operator: No Information
• Device Model Number: 13002SV-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Distributor Facility Aware Date: 06/03/2020
• Device Age: 6 YR
• Date Report to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization