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

Model Number	K320DFA-ELR
Medical Device Problem Codes	Material Fragmentation (1261); Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We never received the similar mdr, complaints for the same product over the past three years.There's no change on the design of the item.We attached a copy of the final quality inspection record on this particular piece of device bearing s/n#(b)(6).The manfacture date of this particular piece of device is 02/18/2020.
Event or Problem Description
We received the email from our customer drive, the details as below: the medical device involved in the incident is a wheelchair, model number # k320dfa-elr with serial number # (b)(6).While using the device the end-user was rolling down the hill.The device hits a little bump, and the side of the wheelchair by his hips cracked.He sustained a slash at the top of his arm.The end-user lives in a rehab center.Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution to meet reporting deadlines we will file a follow-up when additional data becomes available.

• 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: 18026648
• Report Number: 3014810929-2021-00001
• Device Sequence Number: 7664996
• Product Code: IOR
• UDI-Device Identifier: 00822383133904
• UDI-Public: 822383133904
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: K320DFA-ELR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 10/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male