MAUDE Adverse Event Report: INVACARE FRANCE OPERATIONS DEMO 1 MYON FOLDING WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number ACTION3

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 03/07/2015

Event Type  malfunction  

Event Description

Client tipped out of chair whilst trying to place his foot back on the footplate and received a bang to head.Client advised of stability issued and information that a "helping hand" may be useful.The device was delivered with anti tipper devices, it is unclear how the incident occurred based on the information obtained.Invacare is attempting to obtain more information.

Manufacturer Narrative

The device was delivered with anti tipper devices, it is unclear how the incident occurred based on the information obtained.Invacare is attempting to obtain more information.The action 3 is the same /similar to the myon which is manufactured and/or marketed by invacare in the u.S.The alleged incident occured in the (b)(6).

• Brand Name: DEMO 1 MYON FOLDING WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE FRANCE OPERATIONS; route de saint roch; fondettes 3723 0; FR 37230
• Manufacturer (Section G): INVACARE FRANCE OPERATIONS; route de saint roch; fondettes 3723 0; FR 37230
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4701208
• MDR Text Key: 15319067
• Report Number: 1525712-2015-02558
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/19/2015

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: Lay User/Patient
• Device Model Number: ACTION3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/17/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other