MAUDE Adverse Event Report: UNKNOWN WHEELCHAIR COMPONENTS; 890.3920

Model Number T94HA_PTO_37804

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It has been reported by the dealer that both release levers were slightly bent out of box and they will not attach to the chair.

• Brand Name: WHEELCHAIR COMPONENTS
• Type of Device: 890.3920
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4111064
• MDR Text Key: 4716985
• Report Number: 1525712-2014-06212
• Device Sequence Number: 1
• Product Code: IML
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T94HA_PTO_37804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• 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