MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Codes	Laceration(s) (1946); Sepsis (2067)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report provided claims as the end-user was attempting to traverse up a portable ramp, approximately mid-way up the ramp the device was reported to have veered to one side allowing the device to fall off the side of the ramp and land on to its side.The end-user described as sustaining a laceration to one of their toes which reportedly was not properly cleaned which later became septic resulting with the end-user requiring hospitalization to address.This event was reported to have occurred while traveling in another state from their home, and the end-user was not forthcoming as to the height of rise or length of ramp being used at the time of the incident.The power wheelchair was evaluated by permobil representative where it was found to be fully functional with no notable operational deviations as described by the end-user as having occurred.Permobil is unable to confirm a product malfunction had occurred and therefore is unable to reach a determination as to possible root cause without speculation.The dhr was reviewed and device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as end-user was driving their power wheelchair up a portable ramp, when reaching the middle of the ramp the wheelchair reportedly veered to the side forcing the wheelchair, with the end-user, to fall on to its side.
Additional Manufacturer Narrative
Report provided claims as the end-user was attempting to traverse up a portable ramp, approximately mid-way up the ramp the device was reported to have veered to one side allowing the device to fall off the side of the ramp and land on to its side.The end-user described as sustaining a laceration to one of their toes which reportedly was not properly cleaned which later became septic resulting with the end-user requiring hospitalization to address.This event was reported to have occurred while traveling in another state from their home, and the end-user was not forthcoming as to the height of rise or length of ramp being used at the time of the incident.The power wheelchair was evaluated by permobil representative where it was found to be fully functional with no notable operational deviations as described by the end-user as having occurred.Permobil is unable to confirm a product malfunction had occurred and therefore is unable to reach a determination as to possible root cause without speculation.The dhr was reviewed and device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as end-user was driving their power wheelchair up a portable ramp, when reaching the middle of the ramp the wheelchair reportedly veered to the side forcing the wheelchair, with the end-user, to fall on to its side.

• Brand Name: PERMOBIL M3
• Common Device Name: 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: 13583502
• Report Number: 1221084-2022-00005
• Device Sequence Number: 5526859
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: M3
• 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: 02/04/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 109 KG