MAUDE Adverse Event Report: PERMOBIL INC PERMOBIL M CORPUS VS; POWERED WHEELCHAIR

Model Number	M CORPUS VS
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	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial meeting was to show the device and to take measurements of the user's body.The device was adjusted to meet the client's physical needs, and the device was returned for final fitting and operational with the end-user.Report indicates during the second meeting for evaluation of a standing wheelchair, during the evaluation as the user was being stood, they started to show signs of distress and discomfort.Report states the end-user was immediately removed from the seating and later taken to the hospital where they were diagnosed as having sustained a fracture to the right tibia.Reports indicate the user's family, dealer atp, and home health pt were present with the permobil representative.During the evaluation, no noticeable issues were seen, and all parties were acceptive of the users' positioning.After the end-user was removed from the m vs's seating, the permobil representative and user's father did a side-by-side comparison with the user's current home standing frame.It was noted that all measurements were nearly identical with minimal differences.The device was found to be fully operational with no mechanical or electrical deviations.It remains unclear to all parties present as to the root cause of the reported injury.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Report received while conducting an evaluation for a standing wheelchair, the end-user reportedly sustained an injury to their leg which required medical intervention to address.

• Brand Name: PERMOBIL M CORPUS VS
• 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: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 17740974
• Report Number: 1221084-2023-00019
• Device Sequence Number: 12174513
• Product Code: IPL
• UDI-Device Identifier: 17330818002003
• UDI-Public: 17330818002003
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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: Other
• Device Model Number: M CORPUS VS
• 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: 08/22/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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