MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M5 CORPUS; POWER WHEELCHAIR

Model Number	M5 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service provider reported as the end-user was attempting to enter their adaptive van via the incorporated ramp, the device was inadvertently maneuvered to close to the ramp side which allowed one of the caster wheels to drop over the edge.This action caused the device to be unstable, resulting in the device falling over to the side with the end-user.Reports indicate the end-user did not seek medical intervention initially, but reported to have gone to the hospital for an evaluation 2 days after the event due to pain in their leg which had not subsided since the event date.The end-user was reluctant to provide the outcome of the medical evaluation, other than having continued pain in their leg.The device was put through a full operational test to which no abnormalities were noted, less the damages sustained as the result of the fall.System logs were reviewed and no abnormalities were noted.After evaluation having found the device to be fully operational with no notable issues with the drive characteristics, combined with the end-users testimony of events, the service provider concluded this event as being use error.The dhr was reviewed and the device met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was in process of entering their adapted transport van, the right caster wheel dropped over the edge of the ramp.This caused the wheelchair to become unstable and fall over on its side with the end-user remaining in the seating.It was reported the end-user sought medical intervention for undisclosed injuries.

• Brand Name: PERMOBIL M5 CORPUS
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 9452199
• Report Number: 1221084-2019-00058
• Device Sequence Number: 14005613
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: 17330818334562
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: M5 CORPUS
• 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: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• 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: 118