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

Model Number ATC19-BL

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user, who stated that "the back of it broke off right straight across both sides," causing her to fall backwards and land on the floor.She reported sustaining some bruises on her hips, and that "her whole body was stressed." she used her life alert device to obtain medical attention, and was in the hospital for 6 days, however, did not sustain any injuries besides the bruising.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: 15553399
• MDR Text Key: 301285093
• Report Number: 2438477-2022-00098
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383133621
• UDI-Public: 00822383133621
• 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: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ATC19-BL
• 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: 09/08/2022
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 12/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female