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

Model Number	M300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service provider reports having inspected the device and noted the right rear caster fork having detached from the suspension arm.Provider stated the bolt of the friction brake kit which secures the fork to the suspension arm appears to have loosened and backed out, allowing the fork to detach.Review of the dhr indicates service having been performed 2 months prior to the reported event to where the service provider had ordered new friction brake kits.Provider confirmed having ordered these components and having installed them on the device prior to the reported event.Service provider could not confirm if the correct installation procedures were followed when service was performed.Permobil cannot confirm if correct torque was applied to the attaching hardware as outlined in the service instructions.Service provider reports having reinstalled the fork and replaced the mounting hardware with new and confirmed having installed and torqued according to specification as outlined in the service manual.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was driving his device out of doors, the right rear caster fell off the chair.End-user reports they were able to retrieve the lost wheel and continue home to call for service.No injuries were reported to have occurred because of this reported event.

• Brand Name: PERMOBIL M300
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 7999280
• Report Number: 1221084-2018-00067
• Device Sequence Number: 1190171
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: M300
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78