MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY; CEILING LIFT

Model Number CL650 MT

Device Problem Misassembled (1398)

Patient Problems Fall (1848); Head Injury (1879); Intracranial Hemorrhage (1891)

Event Date 01/24/2023

Event Type  Death  

Event Description

Two sections of ceiling lift track separated from the track union mounting bracket as the patient was being lifted from a shower chair.Patient fell to the floor and the ceiling lift motor hit the patient in the head.

• Brand Name: EZ WAY
• Type of Device: CEILING LIFT
• Manufacturer (Section D): EZ WAY, INC.; 710 east main street; clarinda IA 51632
• MDR Report Key: 16502492
• MDR Text Key: 310888117
• Report Number: 2183887-2023-00001
• 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): Y
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CL650 MT
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male