MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number MPV5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Complaint, Ill-Defined (2331)

Event Date 08/16/2018

Event Type  Death  

Manufacturer Narrative

No malfunction suspected.The end user's medical records indicate the end suffered a stroke while seated in the power wheelchair.

Event Description

The end user's friend reported that the end user experienced a medical event while seated in the power wheelchair.

• Brand Name: HOVEROUND
• Type of Device: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfiled industrial way; sarasota FL 34243 4047
• Manufacturer (Section G): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota FL 34243 4047
• Manufacturer Contact: debra silvers ; 2151 whitfield industrial way; sarasota, FL 34243-4047 ; 9418002436
• MDR Report Key: 7920259
• MDR Text Key: 241263262
• Report Number: 1056601-2018-00016
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MPV5
• Was Device Available for Evaluation?: No
• Device Age: 3 MO
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Death
• Patient Age: 63 YR
• Patient Weight: 90