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

Model Number S300PN

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 05/03/2015

Event Type  Injury  

Event Description

During a transfer from a chair of a (b)(6) patient in a light stand the end of the actuator cap broke.The patient fell to the floor and bruised her tail bone.She was taken to the hospital and was later released.

Manufacturer Narrative

Upon learning of the incident, an ez way representative met with the patient and her family and photographed the light stand.Upon examination, it was found that the folding actuator had not been properly slid into the actuator positioning guide by the end user prior to usage as instructed in the operating manual and as stated on the label directly above the positioning guide.Upon usage, the force of the motor in the incorrect position placed extensive pressure on the actuator, causing it to break.A replacement unit was provided to the patient and the damaged unit was picked up by ez way.

• Brand Name: EZ WAY LIGHT STAND
• Type of Device: SIT TO STAND
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA
• Manufacturer Contact: mary landhuis ; 807 e. main st.; clarinda, IA 51632 ; 7125425102
• MDR Report Key: 4827924
• MDR Text Key: 5910620
• Report Number: 2183887-2015-00002
• 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: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/03/2015

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: S300PN
• Device Catalogue Number: S300PN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2015
• Initial Date FDA Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Weight: 77