MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWER WHEELCHAIR

Model Number M300

Device Problems Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 12/15/2018

Event Type  Injury  

Manufacturer Narrative

The end-user described they were driving up to the front door in their home and when reaching for the door knob, claim the device accelerated forward slamming the footplates into the wall.End-user described the footplate folded upwards due to the impact which reportedly bent their foot upwards as a result.Reports claim the following day their lower leg was starting to swell and they went to the er where it was determined they had sustained a fracture to their right tibia/fibula just above the ankle.The end-user reports this event occurred approximately 2 years prior and cannot recall if they had notified their service provider at the time.The end-user reports having continued to utilize over the last 2 years without having any similar occurrences.Neither permobil nor the service provider have any record in their systems of this event having been reported during that time frame, with the dealer only having become aware just recently during an unrelated service call.Service provider reported having evaluated the device finding it fully operational and was unable to duplicate the reports of unintentional movement as described as having occurred 2 years prior.With the information provided, permobil is unable to confirm a malfunction occurred and therefore is unable to reach a determination of possible root cause without speculation.The dhr was reviewed and device was found to have met specification prior to distribution.

Event Description

End-user reports while attempting to open the front door of their home, the device allegedly accelerated forward causing the footplate of the seating to be driven into the wall.Reports claim the impact resulted in an injury to their right leg requiring medical intervention.

• Brand Name: PERMOBIL M300
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke dr.; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 11321978
• MDR Text Key: 232152929
• Report Number: 1221084-2021-00004
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M300
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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): Hospitalization; Required Intervention