MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE; LIFT, PATIENT, NON-AC-POWERED

Model Number	13023SV
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift by the end user's son, who stated that the lift dropped down suddenly while in use and caught the end user's feet under the lift.The end user reportedly fractured his left foot and required stitches on his right foot.Drive made repeated attempts to gain additional information and have the product returned for inspection, but the complainants did not respond.If pertinent information becomes available to drive at a later date, an addendum to this report will be filed.

• Brand Name: DRIVE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping dist.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 18049222
• Report Number: 2438477-2023-00139
• Device Sequence Number: 20699372
• Product Code: FSA
• UDI-Device Identifier: 00822383135441
• UDI-Public: 822383135441
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2023
• Report Date (Section F): 11/01/2023

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: 13023SV
• Device Catalogue Number: 13023SV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2023
• Event Location: Home
• Date Report to Manufacturer: 11/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/01/2023