MAUDE Adverse Event Report: DRIVE MEDICAL THE ZOOME 3 ELECTRIC SCOOTER; MOBILITY SCOOTER

Model Number ZOOME 3

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem Fall (1848)

Event Date 12/05/2017

Event Type  No Answer Provided  

Event Description

The fork of my drive medical mobility scooter zoome 3 broke while riding it.This caused the front tire to dislodge from the scooter causing me to flip frontwards and be thrown from the scooter.Incident location: (b)(6).Product description: from the manufacturer: the zoome 3 is a modern recreational electric scooter providing personal transportation for everyone.The comfortable extra-wide seat is removable, so you can stand up or sit down while riding it making it great for recreational or mobility use.The zoome 3 comes with a powerful 350 watt brushless hub motor providing a top speed of 15 mph, and a maximum range of 17 miles on a full charge.Retailer: (b)(6).The product was damaged before the incident: yes.The damage was repaired prior to the incident: yes.The product was modified before the incident: yes.Purchase date: (b)(6) 2017.Explanation: the fork broke previously and had been replaced with the fork supplied by the manufacturer.Their response this time was they could not do anything.Report number: (b)(4).

• Brand Name: THE ZOOME 3 ELECTRIC SCOOTER
• Type of Device: MOBILITY SCOOTER
• Manufacturer (Section D): DRIVE MEDICAL; 99 seaview blvd. ; port washington NY 11050
• MDR Report Key: 7391605
• MDR Text Key: 104410803
• Report Number: MW5076259
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ZOOME 3
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR