MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY STAND; SIT TO STAND LIFTING DEVICE

Model Number 898

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Fall (1848); Bone Fracture(s) (1870)

Event Date 03/12/2014

Event Type  Death  

Event Description

A cna was transferring the resident from a bed to a wheelchair with an ez way stand.During the transfer, the loop of the harness came off of the hook on the left side of the stand arm.The safety tab on the hook was not on the hook of the left side where the loop came off the hook.The patient fell out of the harness and onto the floor.The resident sustained two fractured vertebra.The patient was taken to the hospital, and returned to the long term care facility where she expired 5 days following the incident.

Manufacturer Narrative

An ez way representative went to the facility to investigate the situation.The facility contact stated that the cna who was transferring the resident did not have any training on the use of the stand and no longer works at the facility.They stated they did not really know what happened.The facility replaced the stand arms with new arms and safety tabs.Per ez ways operating instructions, all caregivers must receive training on the use of the equipment prior to use with a patient, as well as the need to check to see that all safety equipment such as the safety tabs is in place prior to use.

• Brand Name: EZ WAY STAND
• Type of Device: SIT TO STAND LIFTING DEVICE
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA
• Manufacturer Contact: mary landhuis ; 807 e. main; clarinda, IA 51632 ; 7125421810
• MDR Report Key: 3735837
• MDR Text Key: 20107725
• Report Number: 2183887-2014-00001
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/01/2014

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
• Device Operator: Health Professional
• Device Model Number: 898
• Device Catalogue Number: 898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 95 YR
• Patient Weight: 58