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

Model Number 898

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

While raising a pt in an ez stand, the top connection point of the actuator wore through causing the stand arms to lower, along with the pt.The staff reported the pt was not seriously hurt but did have bruising on the face/head and right knee pain.Per ez way s preventative maintenance check list, the connection points on the actuator should be checked for wear on a monthly basis and greased as needed to prevent wear.Proper inspection and equipment maintenance would have prevented the wear.The equipment had been in use for 10 years.

Manufacturer Narrative

Ez way sent out a preventative maintenance reminder letter in april of 2014 to all ez stand owners along with an add'l copy of the required maintenance checklist as a reminder of the importance of properly maintaining ez way equipment.

• Brand Name: EZ STAND
• Type of Device: SIT TO STAND DEVICE
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA
• Manufacturer (Section G): EZ WAY, INC.; 701 e. washington st.; clarinda IA 51632
• Manufacturer Contact: 701 e. washington st.; clarinda, IA 51632
• MDR Report Key: 3952868
• MDR Text Key: 4645213
• Report Number: 2183887-2014-00003
• 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: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2014

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?: Yes
• 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: Not provided
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2004
• 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