MAUDE Adverse Event Report: INVAMEX MANUFACTURING MYON SWINGAWAY WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number NA:MYON

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Invacare was made aware of this event which occurred in the (b)(6) involving an action 3 wheelchair which was manufactured by invacare (b)(4).Invacare is filing this report because the myon wheelchair made at invacare owned invamex and sold in the u.S.Has been determined to be similar in design to the action 3.If more information is received a follow up will be filed.

Event Description

An engineer was delivering a action3 manual wheelchair to (b)(6) hospital.He was in the process of removing the chair from his van when the push handles came detached from the chair as he was pulling it.He fell over and fell out his van and rolled on the ground.He sustained no injuries.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFATURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8170635
• MDR Text Key: 130634680
• Report Number: 9616091-2018-00021
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NA:MYON
• Device Catalogue Number: MYON
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1