MAUDE Adverse Event Report: UNKNOWN MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT; 890.3800

Model Number L-4R

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

End user stated that new batteries in his l-4r scooter only lasted 30 minutes, user was stranded outside on the sidewalk.

• Brand Name: MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
• Type of Device: 890.3800
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3747499
• MDR Text Key: 15178321
• Report Number: 1525712-2014-01836
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2014

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: L-4R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/14/2014
• 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
• Patient Age: 62
• Patient Weight: 68