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	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user's daughter contacted permobil representative to report the end-user was found on the floor of their residence by nursing staff.It was reported the end-user was rushed to the hospital with an o2 saturation level of 72, and reports of sustaining a fractured femur that required surgery to address.The daughter stated the device seating was found to have been in a partial stand position, and with the medical reports provided to her, appears the end-user has sustained a cardiac arrest, and it is the daughter's opinion that the end-user sustained the heart attack while seated, and when falling forward, hit the switch box to initiate a stand function.The device was reported to remain fully operational with no signs of a malfunction having occurred.No claims or allegations were presented to permobil of any product malfunction having occurred to which this event can be attributed.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming the end-user was found in their room, on the floor, after having fallen out of the device seating.This event resulted in an injury requiring 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 AB; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 21162257
• Report Number: 1221084-2025-00002
• Device Sequence Number: 13144160
• Product Code: IPL
• UDI-Device Identifier: 17330818002003
• UDI-Public: (01)17330818002003(11)231212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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: 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: 01/15/2025
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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