MAUDE Adverse Event Report: PERMOBIL AB PERMOBIL C300 CORPUS; POWERED WHEELCHAIR

Model Number C300 CORPUS

Device Problems Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 03/17/2023

Event Type  Injury  

Event Description

Permobil ab, in sweden, recevied a report claiming as a caregiver was attempting to transfer the end-user from the power wheelchair to the bed.The joystick was hit by the caregiver which caused the wheelchair to move and collide into the side of the bed.This action reportedly resulted in an injury to the end-user requiring medical intervention.

Manufacturer Narrative

Information received claims as a caregiver was assisting in transferring the end-user from power wheelchair to their bed, the caregiver inadvertently contacted the joystick knob with their body.This reportedly caused the device to initiate a drive command, forcing the wheelchair into the bed frame resulting in the end-user sustaining a fractured tibia.Service provider reports having inspected the device and found it to remain fully operational with no notable issues.With testimony from the end-user claiming an oversight of leaving the device powered on during a transfer, it is permobil's determination this event was caused by inadvertent use error.The end-user was re-educated to the warnings in permobil c300 use manual where it is outlined the wheelchair needs to be turned off when moving in or out of the seating.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL C300 CORPUS
• 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: 16771152
• MDR Text Key: 313599729
• Report Number: 1221084-2023-00008
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K041219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: C300 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2013
• 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