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

Model Number	M300 HD
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dealer reported while the end-user was operating the device out-of-doors, the circuit breaker reportedly tripped causing the device to suddenly stop.It was reported this sudden stoppage caused the end-user to lose positioning in the seating and fall forward, out of the seating to the ground.Reports indicate the end-user was taken to the local hospital but information as to if any serious injury was sustained, or extent of injury is not being provided to permobil.Permobil representative picked up the device from the dealer and inspected its functionality.During testing of the device, permobil was able to recreate the anomaly when driving the device off a curb and driving over rough, uneven terrain.Further inspection shown the rear shroud cover was not properly seated and when flexing the suspension, the rear shroud cover would shift, hitting the circuit breaker switch.It was also noted the rear caster would contact and shift the cover during directional changes.Once shroud coverings were reseated to the proper position, further operational testing was performed over same environmental conditions with no further issues.Permobil is unable to reach a determination as to how the covering became improperly positioned without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.
Event or Problem Description
Reports while end-user was driving the device out-of-doors, the circuit breaker allegedly tripped causing the end-user to fall out of the seating to the ground where they were subsequently taken to the hospital.

• Brand Name: PERMOBIL M300 HD
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 12417692
• Report Number: 1221084-2021-00030
• Device Sequence Number: 4377949
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M300 HD
• 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: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 136