MAUDE Adverse Event Report: INVAMEX SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

Dealer states units are stripped out.Unit was with patient when left and right brakes failed.Usage of chair 4 months , indoor use.And replace parts.

• Brand Name: SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4456953
• MDR Text Key: 5318917
• Report Number: 9616091-2015-00299
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOLARA3G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• 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