MAUDE Adverse Event Report: INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL

Model Number T4

Device Problems Break (1069); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

Dealer states the chair was just unboxed and one spoke was broken and missing.

Manufacturer Narrative

Product was returned for evaluation.Returns expanded evaluation report states: utilizing existing complaint information, actual observations.And functional testing of the returned product in its "as received" condition, the complaint was confirmed for the broken spoke.Underlying cause could not be determined.

Event Description

Product was returned for evaluation.Returns expanded evaluation report states: utilizing existing complaint information, actual observations.And functional testing of the returned product in its "as received" condition, the complaint was confirmed for the broken spoke.Dealer states, the chair was just unboxed and one spoke was broken and missing.

• Brand Name: TRACER TRANSPORT CHAIR 19 X 16 9153647029
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5039266
• MDR Text Key: 25148749
• Report Number: 9616091-2015-02164
• 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
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• 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): Other