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

Model Number	13023SV
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a patient lift device.The reporter indicated that the user sustained a 4-5 inch cut across her leg by the release valve of the patient lift device when the user was being guided over the bed.The user received treatment by the nurse who applied binding paste to the cut.The investigation is ongoing and a follow up report will be submitted when the manufacturer has completed the investigation.

• Brand Name: DRIVE
• Common Device Name: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping dist.; shenyang, 11000 4; CH 110004
• MDR Report Key: 17846022
• Report Number: 2438477-2023-00127
• Device Sequence Number: 11849672
• Product Code: FNG
• UDI-Device Identifier: 00822383135441
• UDI-Public: 822383135441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/29/2023
• Report Date (Section F): 09/29/2023

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: 08/30/2023
• Event Location: Home
• Date Report to Manufacturer: 09/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2023
• 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: 09/29/2023