MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M1; POWERED WHEELCHAIR

Model Number	M1
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349); Retroperitoneal Hemorrhage (4483); Multiple Fractures (4519); Vertebral Fracture (4520)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil was sued as one of four defendants in a lawsuit where it was alleged, among other things, that the permobil m1 caster wheel became stuck between in the flangeway of a railroad track as the user attempted to cross over the railroad tracks.The user claims the caster wheel fell into the flangeway and the wheelchair became stuck, leaving the device unable to move off the tracks.The user claims to have exited the wheelchair and laid on the railroad tracks.Reports indicate that an amtrak passenger train struck the device and the user resulting in serious injuries.This event occurred over two years ago.Review of the client files indicate no report of this incident was received in or around the time of the event.Currently, permobil has not been able to perform an inspection and has not yet confirmed the exact location of the wheelchair.At this time, permobil cannot reach a determination as to possible root cause(s) that may have caused or contributed to this event.Upon receipt of any new information, a follow-up report will be submitted.The dhr for this device was reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
Permobil legal counsel received petition claiming while the end-user was attempting to cross some railroad tracks, the caster wheel reportedly fell between the tracks, getting stuck, leaving the end-user unable to move the device where they were reported to have been struck by an oncoming train resulting in serious injuries to the end-user.Injuries reported having been sustained are retroperitoneal hematoma, pelvic and spinal fractures, and unsalvageable injuries to his legs resulting in amputation.

• Brand Name: PERMOBIL M1
• 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: 13028080
• Report Number: 1221084-2021-00044
• Device Sequence Number: 16588774
• Product Code: ITI
• UDI-Device Identifier: 17330818252316
• UDI-Public: 17330818252316
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: M1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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: Male
• Patient Weight: 77 KG