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

Model Number	13023SV
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a patient lift.We have not received the device for evaluation.We are filing this report in an over abundance of caution and to be timely.We will file a follow up once more data is available.The patient fell in the living room.The device was engaged to lift the patient.The caregiver used the pump handle to raise him from the floor.A cap disengaged from the device and hit the patient.Then the lift dropped him and he hit his head.When the caregiver turned from pumping the handle he discovered the boom had bent totally down just beyond the hydraulic connection.

• Brand Name: DRIVE
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping district, shenyang 11000 4; CH 110004
• MDR Report Key: 11705918
• Report Number: 2438477-2021-00013
• Device Sequence Number: 19806847
• Product Code: FSA
• UDI-Device Identifier: 00822383135441
• UDI-Public: 822383135441
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/22/2021
• Report Date (Section F): 04/23/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 13023SV
• Was the Report Sent to FDA?: Yes
• Device Age: 40 MO
• Event Location: Home
• Date Report to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 115
• Date Report Sent to FDA: 04/23/2021