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

Model Number M300

Device Problems Unintended Collision (1429); Unintended Movement (3026); Device Fell (4014)

Patient Problems Bone Fracture(s) (1870); Damage to Ligament(s) (1952)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

The device is equipped with a mid-line joystick mount which was reported to have been purchased 1 year prior by the service provider from a third party source.It was reported that while the end-user was in the device seating, the caregiver positioned the mid-line mount to where the joystick was hanging below the seating and to the side.While positioning, it was reported the mid-line mount came unlocked and swung down further which allowed the joystick to contact the device chassis.When this occurred, the joystick handle was deflected in the forward position which sent a drive signal to the device causing it to accelerate, driving forward into a wall where the end-user suffered injuries to both legs to include a broken femur and torn ligaments in both feet.Service provider is evaluating the mount to determine the possible cause for it to have come out of position.There are no indications the permobil device had malfunctioned or have deviated in design.The dhr was reviewed and device met specification prior to distribution.

Event Description

Received report that while caregivers were repositioning the end-user in their chair, the mount to which the joystick is attached fell down to the side causing the joystick to engage drive.It was reported the device accelerated, at speed, driving the end-user into a wall where they suffered injuries to both lower extremities.

• Brand Name: PERMOBIL M300
• 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: 7901396
• MDR Text Key: 121444482
• Report Number: 1221084-2018-00055
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 46