MAUDE Adverse Event Report: PERMOBIL AB PERMOBIL F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/04/2024

Event Type  Injury  

Event Description

Permobil ab received a report claiming while the end-user was operating the stand function, the end-user reportedly sustained a fracture to their left tibea.

Manufacturer Narrative

Permobil ab received report via the end-users mother of an event having occurred where the end-user had sustained a fractured tibia while using the devices stand function.The reporter claims the device did not malfunction, but rather suggests the end-user's caregivers had over tightened the knee support blocks in that when the end-user stood, the force pressure of the knee block assembly was too great and this led to a fracture of the left tibia.The device was inspected afterwards by local representative, and was found to remain fully operational.However, it was noted the knee block assembly when stood had very little clearance which would confirm the assembly as being overtightened for that specific user needs.Representative provided the users family an option of different style knee support that is less susceptible for inadvertent adjustments to be made.The dhr was reviewed, and device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB; per uddens väg 20; timrå, S-861 23; SW S-86123
• Manufacturer (Section G): PERMOBIL AB; per uddens väg 20; timrå, S-861 23; SW S-86123
• Manufacturer Contact: anna-karin wahlström ; per uddens väg 20; timrå, S-861-23 ; SW S-86123
• MDR Report Key: 18877282
• MDR Text Key: 337354808
• Report Number: 1221084-2024-00005
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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