MAUDE Adverse Event Report: INVACARE FRANCE OPERATIONS TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number ACTION3

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Device Tipped Over (2589)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

The only information available is that the nut holding the rear wheels had been coming loose regularly, this had been reported on several occasions to the repair team at bradford wheelchair service during the 18 months that client had the wheelchair, a repair engineer attended to tighten this when required.Then on the 15.9.14 the left wheel fell off the wheelchair whilst the occupant (client) was being pushed by an attendant at home.The rear wheel falling off caused the wheelchair to tip and the occupant fell to the floor.The occupant attended a&e following the incident, no injuries were reported.The wheelchair was inspected, it was found that a boss fitted to the rear wheel drum brake (this stops the wheel rotating when the brake is applied) had sheared off, which may have had a part in the wheel coming loose.As a note the wheelchair is in a poor state for a chair that is only 18 months old.

Manufacturer Narrative

The action 3 is manufactured by invacare europe and 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: TRANSPORT 20 IN X 16 IN 9153637574
• 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: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4373063
• MDR Text Key: 5266553
• Report Number: 1525712-2014-08276
• 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: 10/22/2014

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: Lay User/Patient
• Device Model Number: ACTION3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 12/31/2014
• 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
• Patient Weight: 75