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

Model Number SSP220DDA-SF

Device Problem Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a wheelchair by the end users' mother, who stated "her daughter was at school this past wednesday and the chair collapsed on her while sitting in it," causing her to cut her finger.The end user did receive medical attention, the details of which are currently unknown.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.

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
• 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
• MDR Report Key: 15683344
• MDR Text Key: 302581114
• Report Number: 2438477-2022-00106
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383140506
• UDI-Public: 00822383140506
• 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,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SSP220DDA-SF
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2023
• Distributor Facility Aware Date: 09/30/2022
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 12/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 136 KG