MAUDE Adverse Event Report: PERMOBIL INC PERMOBIL M400 HD; POWER WHEELCHAIR

Model Number	M400 HD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received claiming as the end-user was driving their m400-hd outdoors in offroad terrain, the wheelchair reportedly lost upright stability and rolled onto its side, landed atop the end-user.Reports indicate the end-user received injuries requiring medical intervention to address.
Additional Manufacturer Narrative
The end-user reported that while driving outdoors on an offroad dirt trail, the device w/user ended up in a ditch with the device reportedly coming to rest atop the end-user.Reports indicate the end-user was transported to the local hospital where they were diagnosed as sustaining bilateral ankle fractures and fracture of the left fibula and tibia.The end-user did not make any claims or allegations that the device malfunctioned or deviated in any manner to have contributed to this event, nor did they provide any information as to how the device ended up in the ditch.The device was evaluated by technicians who report the device remains fully operational with no signs of a malfunction having occurred.The end-user was not forthcoming as to their actions/inactions leading up to this reported event.As no product malfunction was determined to have occurred, and information as to circumstances leading up to the event were not provided, permobil cannot reach a conclusion as to possible root cause without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL M400 HD
• Common Device Name: POWER 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 dr.; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 14774528
• Report Number: 1221084-2022-00011
• Device Sequence Number: 1334668
• Product Code: ITI
• UDI-Device Identifier: 17330818198768
• UDI-Public: 17330818198768
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 06/22/2022

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: M400 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: 05/24/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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: Prefer Not To Disclose