MAUDE Adverse Event Report: INVAMEX SOLARA 3G DEMO 2 W/70NTAPER 20 IN H MATRX ELITE DEEP BACK; WHEELCHAIR, MECHANICAL

Model Number SM2018F

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The crossbrace was returned for evaluation, and subsequent testing verified the complaint.The seat rail was bent.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Seat rail on crossbrace is bent on left side.

• Brand Name: SOLARA 3G DEMO 2 W/70NTAPER 20 IN H MATRX ELITE DEEP BACK
• 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: 5675893
• MDR Text Key: 45789847
• Report Number: 9616091-2016-00702
• 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: 09/04/2012

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: SM2018F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2012
• Initial Date FDA Received: 05/24/2016
• 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