MAUDE Adverse Event Report: UNKNOWN TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number ISG-6510254

Device Problems Device Tipped Over (2589); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 09/17/2010

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

The consumer was in the store trying out the chair.When he sat down on the seat, the brace around the front wheel allegedly snapped, causing the chair to tip over and the consumer fell.No injury is alleged.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5745432
• MDR Text Key: 48322652
• Report Number: 1525712-2016-02182
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/17/2010

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: ISG-6510254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2010
• Initial Date FDA Received: 06/23/2016
• 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 Age: 68
• Patient Weight: 91