MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISES MCKESSAN BY DRIVE; PATIENT LIFT

Model Number	146-13023SV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/13/2020
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.According to patient's family member, the patient was at a standstill position when the patient lift then tilted, fell on its side and dropped the patient.This caused the patient injury, which led to a hip replacement surgery.Our tech went out to inspect the patient lift and determined there was nothing wrong with the lift to our knowledge , the tech tested the unit, suspended his own weight on the lift and tested the lowering and hydraulic functions of it.Even though no damage or faults were found, the patient lift has then been replaced.

• Brand Name: MCKESSAN BY DRIVE
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISES; no.386-3 qingnian st.; heping dis.; shenyang, liaoning, 11000 4; CH 110004
• MDR Report Key: 10723458
• Report Number: 2438477-2020-00065
• Device Sequence Number: 3312181
• Product Code: FSA
• UDI-Device Identifier: 00612479222274
• UDI-Public: 00612479222274
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/13/2020
• Report Date (Section F): 10/22/2020

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: Other
• Device Model Number: 146-13023SV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2020
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2020
• 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
• Date Report Sent to FDA: 10/22/2020