MAUDE Adverse Event Report: APEX HEALTH CARE MFG., INC. DRIVE; BARIATRIC PATIENT LIFT

Model Number	12345
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/02/2019
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a s patient lift.This report is in response to mw5091616.We are correcting inaccurate data in the report.Patient was in a lift sling when they moved to the right and fell.He was lethargic.He was taken to the emergency room for tests that were negative.No injury as a result of the fall.The lift is 6 years old.There is no deficiency in the lift or the sling.The mw report notes serious injury which is inaccurate.

• Brand Name: DRIVE
• Common Device Name: BARIATRIC PATIENT LIFT
• Manufacturer (Section D): APEX HEALTH CARE MFG., INC.; no. 6, industrial 2nd road; tou chiao industrial park,; min hsiung shiang chiayi - dis, ; TW
• MDR Report Key: 9759554
• Report Number: 2438477-2020-00016
• Device Sequence Number: 16315830
• Product Code: FSA
• UDI-Device Identifier: 00822383117898
• UDI-Public: 822383117898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/26/2020
• Report Date (Section F): 02/26/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 12345
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2020
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/26/2020