MAUDE Adverse Event Report: PERMOBIL AB PERMOBIL C400 CORPUS 3G; POWERED WHEELCHAIR

Model Number C400 CORPUS 3G

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Bowel Perforation (2668); Multiple Fractures (4519)

Event Date 05/05/2022

Event Type  Injury  

Event Description

Received report as end-user was driving their powered wheelchair out of doors along a country road, the wheelchair reportedly drove off the road landing into a ditch.This event resulted in injuries requiring medical intervention to address.

Manufacturer Narrative

Report received claims while the end-user was driving the device on a straight country road, the device suddenly veered to the side and drove into a ditch.This event resulted in the end-user being taken to the hospital, evaluated as having sustained a fractured left femur, broken ankle, and perforated large intestine.The event was reported to have occurred in (b)(6) 2022, with permobil just recently being notified.Reports indicate the end-user had deceased in (b)(6) 2022 (un-related to this event), with all reports provided being 3rd account.Reports indicate the device was evaluated by the service provider after the event and they were unable to determine a product malfunction having occurred, reporting the device to be fully operational with no mechanical or electrical deviations being found.Permobil technicians evaluated the device and found the device fully operational with no indication of a device malfunction having occurred.Permobil is unable to confirm a product malfunction occurred, thus is unable to reach a determination as to probable root cause without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL C400 CORPUS 3G
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB; 20 per uddens vag; timra, S-861 23; SW S-86123
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: anna-karin wahlstrom ; 20 per uddens vag; timra, S-861-23 ; SW S-86123
• MDR Report Key: 16627184
• MDR Text Key: 312116801
• Report Number: 1221084-2023-00006
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K991658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C400 CORPUS 3G
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose