MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL EXPLORER MINI; POWERED WHEELCHAIR

Model Number EXPLORER MINI

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

Patient Problem Concussion (2192)

Event Date 11/03/2021

Event Type  Injury  

Event Description

Received reports while end-user was in a pre-school class, the device reportedly fell over forward allowing the end-user to strike their head against the ground resulting in a slight concussion.

Manufacturer Narrative

Report provided claims while the end-user was utilizing their device in a classroom setting, the teacher noticed the end-user was laying on the floor and the explorer mini device was reported to have fallen over forward.Report indicates the end-user had struck their head during the fall and was diagnosed as sustaining a mild concussion as a result.No reports were provided by the teachers as to what the end-user was doing or if the end-user was standing, sitting, or possibly rocking when the event reportedly took place.According to the teachers, there was no one (student or teacher) within arm's reach along with no debris on the floor nor any other obstacles in the vicinity surrounding the device.No witnesses report having seen the event occur, only seeing the result of the end-user being on the ground.The device was found to be fully operational with no mechanical or physical abnormalities found to which may have contributed to this event.The end-user was reported to remain within the design occupant maximum capacity for the device of 39" in height and (b)(6) of weight, with their measurements being 37" tall @ (b)(6) of weight.As the device remains within design specifications and witness accounts are unclear as to the end-users' actions leading up to the event, permobil is unable to reach a determination as to possible cause without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL EXPLORER MINI
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 12923278
• MDR Text Key: 281671545
• Report Number: 1221084-2021-00041
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EXPLORER MINI
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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): Other
• Patient Sex: Male