MAUDE Adverse Event Report: HOME MEDICAL PRODUCTS, INC. LUMEX; PRO BATTERY POWERED FLOOR LIFT

Model Number LF500

Device Problem Misassembled (1398)

Patient Problem Contusion (1787)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Lift was shipped on 01/10/2019 from the customer location to applied technical services, inc.(ats) for an independent laboratory evaluation to determine the root cause of failure.A verbal preliminary opinion from the engineers following ats inspection was incorrect lift assembly.Once a final written investigation report is received a follow-up report will be sent to the fda, customer and manufacturer.

Event Description

The customer states that while the hospice facility was attempting to lift a patient, the two bolts holding the mast of the lift into the base broke.The lift's boom fell hitting their patient on his head.Patient was taken to the emergency room and suffered from a contusion.Diagnosis and follow-up treatment is unknown.Customer stated they have not received any further updates relating to the patient's condition.

• Brand Name: LUMEX
• Type of Device: PRO BATTERY POWERED FLOOR LIFT
• Manufacturer (Section D): HOME MEDICAL PRODUCTS, INC.; taichung city, ; TW
• MDR Report Key: 8279368
• MDR Text Key: 134182097
• Report Number: 2428983-2019-00001
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LF500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Distributor Facility Aware Date: 12/26/2018
• Event Location: Other
• Date Report to Manufacturer: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 91