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

Model Number 898

Device Problem Break (1069)

Patient Problems Death (1802); Bone Fracture(s) (1870); Head Injury (1879)

Event Date 06/01/2014

Event Type  Death  

Event Description

A resident was being transferred in an ez stand when the tip of the actuator broke.The resident fell, and suffered 3 fractures and hit his head.The patient was hospitalized and later passed away.The ez stand was 12 years old and had not been inspected and maintained properly.A replacement actuator was ordered.An ez way representative stressed the need to properly inspect and maintain the product monthly per the preventative maintenance checklist.A letter and additional preventative maintenance checklist was also sent by the company in april to all ez stand owners reminding them of the importance of properly maintaining ez way equipment.

• Brand Name: EZ STAND
• Type of Device: SIT TO STAND
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA
• Manufacturer Contact: mary landhuis ; 807 e. main, inc.; clarinda, IA 51632 ; 7125425102
• MDR Report Key: 3912429
• MDR Text Key: 4488929
• Report Number: 2183887-2014-00004
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/26/2014

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: 06/03/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2002
• 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