MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD DRIVE; WHEELCHAIR

Model Number	CX420ADDA-SF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
We received the email from our customer drive, the details as below: notification of drive mdr report to fda - item # cx420adda-sf - jiangsu jumao x care medical equipment - ticket # 257017 - 2438477-2020-00048.The medical device involved in the incident is a wheelchair, item # cx420adda-sf with a serial number (b)(6).Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.Drive has not received the unit back for evaluation.If we receive the unit back we will file a follow-up submission.The wheelchair was in use when a bolt came loose from its nut.The wheel came lose.The end-user fell.It is reported that the end-user sustained serious and permanent injuries "including, but not limited to, brain trauma resulting in multiple seizures and brain surgery.".
Additional Manufacturer Narrative
No, we never received the similar mdr complaints over the past three(3)years.There's no a change on the design of the item.We provide a copy of the final quality inspection record on this particular piece of device bearing s/n (b)(6).The manufacture date of this particular piece of device is 3/27/2019.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: belinda deng ; no.36, danyan road; danyang, jiangsu 21230-0 ; CH 212300
• MDR Report Key: 18026613
• Report Number: 3014810929-2020-00002
• Device Sequence Number: 7615346
• Product Code: IOR
• UDI-Device Identifier: 00822383528366
• UDI-Public: 822383528366
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: CX420ADDA-SF
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female