MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVE; LIFT

Model Number	13023SV
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift by a provider, who stated that "the end user was being lifted off toilet when the lift tilted to the left causing the patient to fall to the ground.The end user's husband was able to get the end user moved to bed." it is unknown at this time whether there was any injury or medical treatment.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.

• Brand Name: DRIVE
• Common Device Name: LIFT
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st.; heping dis.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 16495333
• Report Number: 2438477-2022-00139
• Device Sequence Number: 6315960
• Product Code: FSA
• UDI-Device Identifier: 00822383135441
• UDI-Public: 822383135441
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023
• Report Date (Section F): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 13023SV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/27/2022
• Device Age: 6 YR
• Date Report to Manufacturer: 03/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 03/07/2023