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

Model Number EXPLORER MINI

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter describes that during a trial of the explorer mini device, the user backed the device into a therapy table.The backrest of the device contacted the table-top while the base of the device was left unobstructed and the end user continued to drive the device in reverse.This caused the rear wheels to lift from the ground and cause the device to start to lean forward.A therapist was present and was able to steady the device back onto the ground and relocate the device to a different part of the room.The trial continued with no further incidents.A capa ((b)(4)) has been opened to investigate and to identify any necessary corrective actions.The risk assessment has been reviewed with tip risks having been identified, which are communicated by general warning statements, throughout the user manual, that the explorer mini device should only be used when an adult is present and continuously monitoring the child.Although there was no report of injury and no device malfunction was identified, permobil is choosing to report this event in an abundance of caution.The dhr has been reviewed and the wheelchair was found to have met specification prior to distribution.A follow up report will be submitted if any new information is obtained.

Event Description

Reports during a trial of explorer mini, the user backed the device into a therapy table which caused the rear wheels to lift and the device started to tip forward.Therapist was able grab the device and move to a different area before any incident occurred.No injuries were sustained as a result.

• 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: 11101102
• MDR Text Key: 233065559
• Report Number: 1221084-2020-00055
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/31/2020

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: EXPLORER MINI
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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