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

Model Number	SSP216DDA-SF
Medical Device Problem Codes	Device Slipped (1584); Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418)
Date of Event	12/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user, who stated that she was using the wheelchair "on the sidewalk up a ramp," when it was "raining a lot and cold," and where "there were a lot of leaves so it was slippery." she was reportedly "thrown out of the chair" and was rendered unconscious.When she regained consciousness, "the chair was on top of her," and she sustained 3 broken ribs.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the incorrect manufacturer name in section d3 and f14.The information has been updated in these sections to reflect the correct manufacturer name.

• 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
• MDR Report Key: 16274175
• Report Number: 2438477-2023-00002
• Device Sequence Number: 18015545
• Product Code: IOR
• UDI-Device Identifier: 00822383145280
• UDI-Public: 822383145280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023
• Report Date (Section F): 12/08/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SSP216DDA-SF
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 12/08/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 12/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Date Report Sent to FDA: 12/08/2023