MAUDE Adverse Event Report: MAX MOBILITY, LLC SMARTDRIVE

Model Number	MX2
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 10/20/17 (the required filing deadline of mdr report), max mobility, the manufacture of the device and submitter of the initial mdr report, is awaiting additional information and opportunity to evaluate the specific device of this occurrence for thorough investigation.The current information available is incomplete, and it is unclear as to exactly what occurred, as well as how the device contributed to the occurrence.The initial evaluation lends to the occurrence / event being attributed to user / operator error.For this type of failure (user / operator error) with this model, the device design and the control measures to prevent this type of occurrence were reviewed for their sufficiency / acceptability according to the company's established risk management procedures / practices - which was verified.These control measures include instructions for use and cautions, especially for situations to turn the device off and intended use environments.Upon completion of the investigation, a follow-up mdr report will be submitted if deemed necessary (i.E.Device malfunctioned, corrective / preventive action is taken, etc).
Event or Problem Description
As described to max mobility management by court filings that user was operating smartdrive model mx2 - serial number unknown (not initially provided) and "whether due to the awkward fall of [the user] or due to the collision between [the user] and the wheelchair as a result of the wheelchair running him over, [the user] suffered injury and was hospitalized.X-rays revealed the [user] suffered broken bones, including a broken leg.".

• Brand Name: SMARTDRIVE
• Common Device Name: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY, LLC; 5425 crossings blvd.; antioch TN 37013
• MDR Report Key: 6974575
• Report Number: 3008370857-2017-00001
• Device Sequence Number: 1298328
• Product Code: ITI
• UDI-Device Identifier: 00861896000303
• UDI-Public: 00861896000303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MX2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization