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

Model Number CX420ADDA-SF

Device Problem Material Separation (1562)

Patient Problem Brain Injury (2219)

Event Date 12/10/2019

Event Type  malfunction  

Event 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.".

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
• Type of Device: 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
• MDR Text Key: 326807689
• Report Number: 3014810929-2020-00002
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383528366
• UDI-Public: 822383528366
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CX420ADDA-SF
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female