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

Model Number F5 CORPUS VS

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

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

Event Date 11/24/2023

Event Type  Injury  

Event Description

Permobil ab received a report claiming while the end-user was driving the wheelchair, the leg rest function began to elevate without input from the end-user.The report indicates the knee block assembly was installed and when raising, applied excessive pressure to the end-user's legs resulting in injuries requiring medical intervention.

Manufacturer Narrative

Information received thus far from permobil ab indicates the wheelchair was returned to the distributor, and permobil ab are planning for the device to be inspected and evaluated for possible cause of the reported event.Currently there is no information besides the incident description available.As new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specifications prior to distribution.

Manufacturer Narrative

The device was returned to the permobi lab where the wheelchair and its programming were inspected multiple times with the device being found to remain fully operational with no signs of a malfunction having occurred.Suspect components were provided to the respective suppliers for a more in-depth evaluation, with each supplier reporting finding the respective components as being fully operational with no notable deviations being found.Although there were some signs of physical damages to the device and some of the cabling.It was determined that none of these damages would have contributed to the event as described having occurred.After completion of evaluation, permobil ab was unable to confirm a failure having occurred, thus is unable to reach a determination as to possible root cause without a degree of speculation.

• 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: 18381488
• MDR Text Key: 331182806
• Report Number: 1221084-2023-00025
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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